New Pedicle Screw Spinal Implants Need Further Safety Studies: FDA

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By: AboutLawsuits | Published: October 6th, 2009

The FDA has ordered the manufacturers of new, flexible pedicle screw spinal fusion implants, known as dynamic stabilization systems, to conduct more research on potential problems with the devices, including the whether they provide enough stability to allow for complete spinal fusion and the frequency of additional surgery for patients who receive the pedicle screws.

In a press release issued on October 5, the FDA expressed concerns that the spine surgery screws may lead to future complications for patients and indicated that they are requiring manufacturers to conduct post-market surveillance studies for existing systems, and premarket clinical trials for systems currently under development.

Pedicle screw systems are used during back surgery to stabilize the spine and allow the bones to fuse into the proper place. Older pedicle screw spinal implants were rigid and mostly inflexible, but the new dynamic stabilization systems are designed to allow the patient to experience much more flexibility during the fusion process.

Johnson & Johnson and Medtronic both have flexible pedicle screw systems on the market, while another system by Zimmer Holdings, Inc. is currently awaiting FDA approval.

To date, the devices have fallen under the FDA’s controversial 510(k) approval process, which expedites approval of devices that are similar in form and function to existing, approved medical devices without the need for an in-depth review. Critics of the process and a recent Government Accountability Office report claim that the 510(k) approval process has allowed a number of dangerous, unique and virtually untested products to slip past FDA regulators before being thoroughly vetted.

FDA regulators said that there is not enough clinical data on the potential safety issues, indicating that the system components may loosen, bend or break over time. If the pedicle screw fails to provide enough support for fusion or fails over time, this may require patients to undergo corrective surgeries that may lead to serious and even life-threatening complications.

Older pedicle screw system work by installing screws into segments of the spine and anchoring them to metallic rods. The rods immobilized the spine and allowed bones to fuse together. The new dynamic stabilization systems use polymer cords, movable screw heads and springs that allow the patient to bend and rotate while the bones are in the fusion process. The new systems began to appear on the market in 1997.

The FDA is requesting that companies provide data that compares the rate of bone fusion between the old and new devices, and data that compares the incident rates and severity of adverse events and the need for follow-up surgical procedures. The FDA also is looking for information on the causes of any known failures of the new systems, as well as data on the demographics of patients who experienced the failures.

The agency announced that once it has the necessary data, it will decide whether labeling changes or any further action is needed. Currently, the FDA is not recommending any changes.

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There Are 71 Comments So Far • (Add Your Comments)

  1. I have a two level failed spinal fusion that was done in December of 1996 and recently heard that class action suits have been filed against the pedicle screws similar to what is in my spine and causing me so much pain and am seeking information.

  2. I had one of these piece of garbage Medtronic stabilization devices put in my back 2 yrs ago and it broke on me last February. I had it removed and now have no lumbar. Its entirely fused , I’m in massive pain and will never be the same. The surgeon got paid from medtronics but never offered me a thing. Good luck to anyone in this same situation.

  3. Dear Patrick,I’m very sorry to hear that a Surgeon also Ruined your Life with These No Good Defective Metal Screws,that also ruined my Life in1997.I suffer now 24/7 with what they call Severe Chronic Intractable Pain.The Surgeon Assured me that he would make me feel like a New Man once He Did a Anterior & Posterior Approach taking a piece of my left Hip off to put Between My L-5 Disc that was completely Deteriated causing severe Nerve Compression.He said he would also have to use these Metal Pedical Screws to stabalize this area in order for my Disc to Fuse together.I want you to know I didn’t has much get a Body Cast or Brace that I learn later I was to be in for 4 to 6 mo.to avoid any movement on The Screws so The Bone would Fuse.He left Town once he collected almost $27,000 for a one Day Surgery.The Hos.got $48,000 for a 5 day stay.I was in Physical Therapy 6 to 8 wks.later.I kept telling the Doctor that ordered this that my Pain was getting much worst.He insisted that I take my Med.& continue in which I did until I couldn’t go anymore.With-in 6 Mo.the Screws were backing out of my Spine & were on the Nerves, I got to another Surgeon just in Time before one of them had backed completely out I would have been paralized now or Dead.When I explained to The Doctor that Ordered my Physical therapy that had a PH.D,He wound up commiting Suicide.Then I found out The reason The 1st Doctor had left Town, he was running from Multible Law Suits.Now I have no Quality of Life whatsoever,I worked as a Electrician & a Musician my entire Life,now I can barely look after myself.I lost my Dear Wife of 25 yrs.to Cancer. May God have Mercy on all The ones that have Experience this.It’s a money Racket.I heard that a Doctor & His Auto Mechanic Designed These Screws.The FDA should make Sure that these can’t be used for The Spine until Further Studies.I can’t enjoy life at all now because of These no Good for nothin Screws.
    May God Help Those that are Suffering from this.

  4. I had a Double Fusion in Feb of 2005 and was told right from the word go that I would be suffering from pain and that it would get worse as I got older.I found out one day that the Tops of the Screws(the lock nuts that hold the steel rods) came loose I called the surgeons office and they refuse to even return my calls ,I was left with nerve damage from the way i was positioned on the operating table , and Am in constant pain , now to the point that i’m taking Morphine sulphate and Oxycondone at the same time , I went thru physical therapy and it never worked, they told me that the best i could get from therapy was better movement but nothing really for my pain, MY legs go numb and my back goes crazy with spasms , how do you find out if your screws are coming loose, I don;t havae the money to pay for an MRI and my Medicare will not cover it because it was all left over from several Car accidents and thats all concluded. The Doctors office can only tell me to keep taking my pain meds and to try to keep off of my feet a much as possible. Who can live like this ?

  5. I had spinal fusion C4,C5 in 1997. This was traditional fusion using bone graft with hard and soft collars for 3 months and a lengthy rehab. It was very successful and I have had no complications or loss of motion. Then in 2008 I needed to have another fusion of C5, C6. This time the surgeon told me that I need not worry about collars or a lengthy rehab. He informed me that they use screws now and indeed I walked out of the hospital the next day. No collar and a short time in physical therapy.
    At first I was elated. Then about a year out I began to have some pain and stiffness. At two years out I had bouts of extreme pain and considerable loss of motion. Now my pain is constant and at times unbearable. I am to the point of being unable to work and at time cannot safely operate a vehicle. They tell me there is nothing they can do and being self employed I cannot afford the cost of an MRI. I don’t know what to do and was hopeful someone would have some information or advice for me. God help anyone who is or has gone through this.

  6. My husband at the age of 36 had a spine fusion in 2005 and a year later he was rushed in again for non union of the cage. The doctor removed the cage and left him with an unstable spine and severe nerve damage. If these cages and screws are causing so much damage why are they still on the market. My husband would have been better off without the surgery. He suffers so much with pain and keeps loosing the feeling in his legs. To this day we still have not gotten any answers on why this happened. I know what everyone is going through and only hope something is done about
    all complications related to spine surgery.

  7. I read these posted comments and my heart goes out to each of you. I am a 61 year old woman who has had severe scoliosis since the age of 13. I have had 9 surgeries, the last 5 of which were to do posterior and anterior reconstruction and 3 of which were to clean the wound from Serratia marcescens infection that was throughout my blood before they found it. I spent 2 mos. in the hospital, 6 mos. in a body cast, 37 hours of surgery, 8 weeks on IVs at home and a year on oral antibiotics. But all that being said — I am very very thankful and grateful for my surgeon. Yes, I got an deadly infection — any long spinal surgery raises the infection risk out the whazoo. I have about 5-7 pounds of titanium implants fused along both sides of my spine, with pedicule screws bolting the implants to my pelvic for stability. These last 5 surgeries occurred in 1995. I am now 16 years post-op and I have had bouts of severe pain and am now unable to work because I had a desk job — which is the worst if you have a bad back. I only want to encourage each of you who feel trapped or that they have no “quality of life” to please email me and I will give you the name of the best spinal surgeon in the world — he is very very very conservative. If he can’t help you or if additional surgery is not needed he will not do it — and he will always try to find non-surgical alternatives first. This doctor planned my last surgeries for 5 years — during that time, I had a smaller surgery to get me through — he waited until he could no longer wait. I know so many have complained about the botched jobs — but I have no such complaints. And I will tell you that since 1995 I have had many many many good days. This condition does not come with any guarantees. I may even end up in a wheel chair — but for now I am not. I gave up a lot — all flexibility I had left — but in a NY minute — I would do it again, knowing what I know. So again, if you are interested in knowing the doctor’s name, email me. He is located in St. Louis MO. Thank you.

  8. Hey guy’s it’s Stephen from the 4 October 2010 post ,just wanted to update ,it’s now 6 1/2 years after my surgery and I now have a broken or loose screw head . I have sent my latest z-rays to my surgeon for him to evalueate . but on the pain front i have pain thats shooting down my left side and at times cross’ over to my right leg, still on the same medication just srtonger amount. Don’t know how i will fair this go around I’ll be 48 in a few weeks and I have been thru more that i would ever wish on my worst enemy,and it may possibly start all over. Best of Luck To you all I hope you canFind some Pain Releif.

  9. Has anyone heard of any lawsuits against Medtronics for there lowsy CRUD? (recalled pedicle screws?)

  10. I alsp had the spinal back fusion surgery in 10/10 . My screws and bolts have also came loose and causing pain on left side, leg goes numb at different times. The pain is almost as bad as before surgery. I also was told the surgery would make me my life so much better. well it has not happened. In fact the dr that did my surgery has left tje practice. I have seen a new surgeon at same practice, he as since released me from the practice and wants nothing else to do with me.. no pain meds or anything. I need help finding an attorney to help me sue them.
    Each attorney I have contacted is not taking any new cllients.
    I live in South Carolina and had back surgery done in North Carolina.
    Please someone give me some advise.
    Thanks Linda

  11. I was taking the trash out 2 weeks ago and havent walked well since..i got an xray yeasterday and just found out my screws are broken! i had my operation 3 yrs ago . i had a fusion. my pain never goes away! im sick of it. my body cant keep up with me..

  12. I was taking the trash out 2 weeks ago and havent walked well since..i got an xray yesterday and just found out my screws are broken! i had my operation 3 yrs ago . i had a fusion. my pain never goes away! im sick of it. my body cant keep up with me..

  13. failed lumbar fusion constant back pain

  14. had back fusion that failed and broken screw shown on MRI constant pain

  15. I have had 2 sets of screws put in my lower spine, 8 years apart. I had severe pain from the get-go. My 1st dealings with pedicle screws was way back in 1987. I have massive amounts of permanent nerve damage that’s making my leg muscles atrophy. There seems to be many success stories, but it also seems that when it goes bad, it goes very bad, leaving the patient facing a lifetime of pain. That has been my story.

  16. I hadd l1-l3 fused in 2006. I was carrying milk up the hill my house was on and now suddenly the two screws in l1 are broken and coming out. I can hardly walk, and every time I cough, sneeze or move my legs, my back pops and cracks, and the pain is almost unbearable. The doctor’s office at first said yes the hardware was broken, but two months later a different doctor said the same catscan showed they were fine. I call b.s! Is there an attorney I can talk to to sue???? I’m also blind and would need to rely on someone the rest of my life, thank you morons.

  17. I had L-5 S-1 Disc Fusion Jan. 3rd of this yr. 20011 and I just received word today after taking an X-Ray that one of the Titanium Screws has broken into. I Now have to have the whole Surgical procedure again this Jan. 2012. I’m very concerned about the Doctor using the same type of screws. What if this happens over & over again?
    I’m scared.

  18. Sheila, you can find out what they use before hand, additionally, mine in s1 broke too and I was told I could have the surgery again but he would go into the stomach and plate from the front, see if that is an option for you.

  19. I have 2 problems, failed back surgury with 8 screws at 3 levels L-3 to S-1. No fusion and 2 broken pedicle screws, constant pain and just a “wonderful” quality of life, scheduled for repeat surgury (number 5) first week of February 2012. Also had plate installed in neck at C-3 to C-5 and after a year ended up with 2 broken screws there, had the plate replaced a year later and one of the broken screws removed while the surgeon decided to leave the second screw in place. Well guess what, a year later the second screw began to migrate to the surface (as foreign objects will do) and it was caught by my new surgeon just behind my carotid artery on its way to the surface. After 3 surgeons look at its position, only one would even attempt the extraction and he successfully removed it 2 weeks ago. Someone out there tell me what the hell is going on out there. Is there any safe way to correct these problems, and am I destined to be in constant pain for the miserable remainder of my life. I hate to vent but it is getting harder every day to keep my spirits up after all these years. I don’t even want to get into the first Neupro who never followed up on my lower back so it took 3 years of Pain Management (drugs, drugs, drugs as well as a useless spinal implant stimulator) to even find out that there was no Fusion. Any suggestions out there.
    Thanks for listening and my sympathy to everyone else out there, because only we know what we are going through.

  20. I had my first spinal fusion (L5-S1) on October 5, 2010. On June 3, 2011 the surgery had to be redone because one of the screws broke completely in half. I have constance pain in my lower back, tailbone, and left/right legs. My pain management doctor wants me to have the neurostimulator implant. The surgeon that performed my surgeries has left the practice and moved to another state. I can’t get another surgeon to even see me. I’m on 7.5 mg of Methodone and 4 mg of Hydromorphone. These are the only drugs I can tolrate. Spoke with a lawyer and he stated that I may have a chance to sue the manufacuter of the screws and plates. My chances don’t sound very good. He also stated that I would not have a good chance of suing my surgeon. The worst part is that I found out from my lawyer that the L5 vertabre is broke and pressing on the nerve also.

  21. i allso had spine surgey i have a plate and screws in my c-spine back in 2010 i have pain in my neck my arms go numb constance pain in my arms doctors wont talk to me about it real bad burning pain in my sholders i also had donner bones put in plz help with my pain i cant set in a chair very long cant lay at night because of the pain my legs hurt my feet hurt

  22. Just an update, my husband can feel the left-hand l1 screw when he touches my back, if I’m lying down. Anyone can feel the hardware, no matter top or bottom, moving if I stand or walk. The pain is getting worse along with the numbness. I now live in Utah, and the original surgeon is in Texas. Is there any chance of suing?/ Also, I got a chance to have my notes rea d to me. either they’re not telling me the lot and serial number so I don’t have enough information to sue, or the numbers weren’t recorded as per standard protocol.

  23. Hi, I was the age 45 when I had a fusion, spine demonstrate pedicle screws in the L4, L5, and S1 with vertical and horizontal fixation rods in place. Alignment of the lumbar vertebral bodies is anatomic iswritten , and there has been noted a previous L4 and L5 Laminectomy.(defect)Get this a bone plugs in the L5-S1 disk space. Lumbar myelogram images are somewhat limited , the Tech said due to the superimposed metillic hardware., then however there still appear to be asmooth predominantly right side mass effect at the L3-L4 that all causes pain even sitting ,walking maybe this is why I have mobility instability also, then inflammation, I stop walking why ,sometimes?, with finding of spinal stensis at the L3-4, a Myelogram not C1-C2 INJ all Iinjury working for Food service afor the Caddoparish school board on premises of one of the schoolsalone with 50% torn Rotator Cuff only 1/2 to2/3 of cuff was normal, they authorize a arthroscopy, and a Arthoromy with capular shift anyway it deformed effect my daily life activities as reaching , pulling lifting 5 pound only waist level, nocurve as a normal shoulder would…. this is some examples of the surgey.I tried to work light duty and was fitted to a client my employer said in 2009 the created a light duty job a ” sitter” actually the real Title isa Nurses Aid and they reassign me to another client… breaching 2008 job as a sitter and Feb. 5, 2009….. Isustain serious sprains and strains upper extremties and has all sort of inflamations all over….I file to EEOC about the wrong job descriptions, function , duties even the wrong wage information sent by Both employers … who has never file my Real Ingury, or facts that they was disabling even the R shoulder in 1996 this is my periods of Permanent Total Disability…. n I did have disability Ins. on the jobs , covered plans and I was denied ALLLLLL… why…even the Government Guarantee… and Unemployments?

  24. So many horror stories. My son is having the same issues. It has become an epidemic and should be addressed. I am a retired nurse. I am so mortified with the medical field. And so tired of the PAIN MANAGEMENT doctors acting if they are GOD. They are not specialists in this field and yet they recommend what drugs you need and charge you (100-200) for ten minutes of your time. It has become a racket.
    People there is an EPIDEMIC out there.
    Sure there are peopled hooked on drugs after so long…..but they should be helped and doctors should be made to be accountable for these issues.

  25. This is my first time realizing that I’m not along. My first fusion was in 2003 by a high end very popular neurosurgeon out of North Carolina. I never saw any relief from the operation and after 3 years of pain I started to get 2nd, 3rd,and 4th opinions. The problem I ran into was every other doctor in the city just brushed me off and said nothing was wrong. I asked a friend that is a doctor what he thought, and the first think he said is that I needed to go to another network of doctors and get a opinion from a doctor who does not eat lunch and play golf with the one who did my surgery since he is a high profile surgeon. I went out of the city and the new doctor saw that the screws were coming out and they would need to come out and be replaced. I asked if this was something that could have happened over a few weeks and he said there was no way, implying the other doctors ignored the problem via X-Rays,MRI,and Bone scans. Longer story made short after the second surgery in 2006 the doctor handed me the bag of faulty screws and said if I plain to go to court I would need the screws along with my past scans,x-rays, etc as evidence. He told me he would not have used the brand screws used for a L4 , L5 fusion and what he put in my back was the cadillac of screws and rods. Im frustrated now that I did not take action then and now I might be to late to do anything.

  26. Spinal fusion c2-c7 in may of 2009. Stifness pain numbesss tingling burning are just some of the pain I go through. How do you find out what type of hardware was implanted in my neck?

  27. I feel very badly for all of you! I had an EXCELLENT neurosurgeon perform an anterior/posterior L5-S1 fusion in May 2011, and it changed my life for the better. For those of you who had an orthopedic surgeon do your procedure and are still having problems, find a good neurosurgeon. This type of surgeon deals with your nervous and spinal systems simultaneously. While I still have pain, it has been greatly reduced by the surgery, and my recovery time was pretty fast. While I do not know if I can publish my surgeon’s name, I can tell you that “Dr. T” is located in Mount Laurel, NJ at a “Coastal” location dealing with the “Spine”. Got it??

  28. I Have had 4 surgeries. Including screws. I also have titanium cages. My screws were taken out but have horrendous pain still in my back. Does anyone else have problems with there cages? I have to have pain shots in the e.r. about once a month because I can not keep my pain under control. Now I found out I have arthritis in my back at L 3-4. Are we suppose to live the rest of our lives this way. Unfortunately, my is all workmans comp. It is a fight everyday with them. What to do?????????????

  29. spinal fusion with cages never worked .Went into anaphlactic shock in doctors office .Allergic reactions for two years was told its not from sugery almost choked to death in my bathroom .Kept havin scar tissue build up removal Then finally fusion of area with screws and plates from the back have nerve damage pain in left testicle from graft sites on hips

  30. I currently have titainum rods in each leg and a titainium mesh in my spine. Each one of these items of hardware is currently not doing what they are supposed to. According to x-rays and MRIs the screws are comming ot or already out of place. They are lying in tissue no longer screwed into the bones they were originally in. The MRSA that I had is back and probablly killing me as we speak. I intend to contact the recommended law firms to assist me. Please feel free to call or email me at the numbers provided.

  31. I had one of these screws break on me too, i had a double fusion of F4/5 – F5/S1 and about 8 months after the surgery I started having so much pain I couldn’t do PT, it was pre-surgery levels of pain. I went around for a year until I was able to see my original surgeon, until them it was treated with massive amounts of meds, no one believed me that a screw broke or that I tasted metal in my mouth. These original screws were 6.5mm hollow and flexible types, when it was finally confirmed in 2008, yes I had a broken screw, they got me back into surgery and put in six solid 8mm screws, I was instantly better. Though now I have massive amounts of pain from the nerve damage in my lower back. I don’t fault my surgeon, he did what he knows, I fault the manufacturer of the screws and I would like to see them suffer for my suffering.

  32. I would Like to know Who is the maker of the two cages I have inplanted in my back at L5-S1 ?

  33. Way back in 1991 I had a lamenectomy and rods and screws put in with a fusion on top of that. Before I had the surgery, I had good days and bad days, from the time of the surgery to now, I have been in pain 24/7. Pain pills ony make it a little tolerable. Have been to ceveral physicians, nurologists, no one wants to touch me. One of them finally refered me to a ortopedic surgeon and his answer was to go in and take out all the rods and pins and undue the fusion. I was like, I don’t think so. Can’t have any MRI’s done because of the metal just makes the machine zig zag all over the place, making it unreadable. I need to know how to find out what kind of metal and screws are in my back, just so I can figure out if I am having prob.s with them. No physicians have said a word about the screws being bad. Keep being sent to phys. therephy, like that will help. This surgery has made the quality of my life really bad. I am very active and dont let anything stop me from the things i like to do. Even if I am suffering from pain. I also have no discs left in my neck but only thing that will make me have a surgery on neck would be if i was going to be paralyzed or die from it. Anyone have any suggestions? Now I see

  34. I got hurt on job in 2000 and a year later they cut me twice in 9 days and I never did get relief. Then after losing everything in hurricane katrina my L5-S1 and L4-L5 went completly out. I was in tears for wks til I got into the back specialist. He went in a few days later and fused it with skyla zena titanium rods and screws. A few yrs later I started have unbearable pain again and had too start going to pain managment again. About a yr after seeing the Dr he told me I had broken screw and rod in my back and to my knowledge titanium is unbreakable. I was about to have it removed at the beginning of yr and had a pulminary anbulizim. Now I’m stuck on cumidin and stuck in pain. I wouldn’t wiish this on any1. I need to find a good lawyer to sue the company that made this junk in my back.

  35. On May2,1992 my life changed forever . On that day, before surgery I was a beautiful , happy, dealing with my regular shit life ! I had hurt myself at work .
    Don’t wanna get into all the bullshit stuff that happenned between the accident on December 31,1991 & that first surgery . I was diagnosed with having a large lumbosacral disc protrusion & a right -side lumbosacral discetomy was on that day May 2 ,1992.
    I continued to suffer constant pain & on April 12 1994 , another surgeon opperatied . The orthopedic surgion performed an LS-S1 fusion procedure, using bone grats, plates and screws.
    I can’t write r explain the all incompasing PAIN . All the years of PAIn , all the years of drugs to live in this constant pain . The 3 different pain clinics , the mind bending ,the praying ,the hours trying to bargin with god
    This was’ent sapose too happen to someone like me ? I was a good person , I had done everything right , I was the girl that believed her father when he told me ” If your a good girl , a good person , you do whats right, work hard and you always try your hardest you’ll be ok ” You’ll be happy …..You’ll be safe
    I tried so fucking hard . For years , after the first surgery , the second surgery . After drug induced coma’s so I did’ent move , a baby I lost cause I could’ent have it .
    I just kept BELIEVING all the doctors and specialists
    Mind over body , if you want to be healthy yo can , you want the pain to STOP ripping you appart controll it .
    I went to pain clinics thats cost 10′s of thousands of dollar’s . Not cause I could ever of afforded it . They paid because I had hurt myself at work .
    I sit here now , I sit here asking myself ….STILL the allusive can my mind take me away from my body ? Still I don’t want too give up .
    I was so determinded …I spent almost 6 years in physiotherapy , meditating,working my body over , and over . I WANTED to go back to WORK . My life
    I wanted it so bad I ignored what my body was SCREEMING , I ignored how BAD the PAIN was becomming , I wanted too be OK I wanted too believe !!!!!!
    I ended up lasting 2 more years . Only about 3 month into it with out taking huge amonts of pain killers . Constantly ignoring what my body , what my PAIN level was telling me
    5 years ago , I had my 3thd surgery . They took a piece of my hip & fused my neck . The surgion said too me ” Don’t worry , this is nothing close too what you’ve been through ”
    He was right
    I am so broken , nothing helps , long term morphine , short term morphine for the break through pain , coke , vodka …….
    NOTHING

  36. My son had scolosis surgery in December 2010 and never work up from the surgery had a massive stroke and died all because of this surgery

  37. MY NAME IS MISTY AND I JUST CONTACTED MY ATTY AB MY BROKEN SCREWS IN MY BACK. I’M REACHING OUT TO OTHERS TO PLEASE CONTACT ME IF YOU ALSO HAVE BROKEN SCREWS. I’M IN NASHVILLE TN BUT DOESN’T MATTER WHERE YOU ARE. I’M WANTING TO SPEAK TO PEOPLE ABOUT THE BRAND OF SCREWS AND WHEN YOU HAD SURGERY. MY ATTY SAID I COULD REACH OUT AND GATHER INFO TO MAYBE LOOK INTO FILING A LAWSUIT AGAINST THE MANUFACTURER. PLEASE CONTACT ME ASAP

  38. In March my husband had a back fusion surgury . He is still in pain and last month when he went for check upthe doctor told him that one of the screws has cracked one of the bones Is this normal. He told him to go home and wait for months and then he would do an exray to see if the crack has gotten any bigger (he has not gone back to work yet), but he is doing some walking and excercise at home but says that his is in pain

  39. Hi my name is Tammy, I had a cervical fusion done in 2007 and in 2010 I had an xray done and found out a screw broke in my neck which when I moved my chin down the back of my neck was opening up exposing my nerves and spinal cord, my dr immediately had to do surgery on me and he was not able to get the screw all the way cleaned out of my bone which he could not put a new plate in the front of my neck so he had to turn me over two days later to install rods in the back of my neck to make my neck stable so it would not open up. I am in constant pain everyday now because I had to be cut in the front of my neck and also cut on the back of my neck from the base of my skull to my shoulder blades. I feel that there should have been no reason for a screw to fail and break in half therefore cause me to have two more surgeries and causing me chronic pain which I will be in for the rest of my life, it is hard for me to deal with life on a daily basis or basically living a normal life ever but I do it anyway but not easy.

  40. Hello, my name is Bettye, I was the age 32 when I injured my cervical spine, and was since at Kaiser Hospital, the treating doctors never did and MIR or C sane nor X-ray, what they did do is to give me pain meds for 18 years. Both in pain and poor and did not know what to do with Kaiser, I change my medical plan to Blue Cross Blue Shield a PPO. It was then I was free to see other Physicians. Did tell you’ll that I was an Federal Employee on (OWCP) this made it hard to get medical payment after I had change plans I paid medical out of my pocket. This lead to my not being diagnosed correctly they reported I had neck pain, and pain in both arms, which affected the left side of my body, the said chest this was incorrect women have breasts and not chests, in that, my neck pain was simply a little swollen this was incorrect I was cocked to the left. Kaiser was not required too write a full report so they on there document. The harm that Kaiser did just further added to my suffering and harm to my not being diagnosed. My treatment plan which was a mediations driving program. When finely got the correct diagnosed of C3 thru T1 and T2 after 18 years of pain and pills. I Find the first doctor that did surgery in 2000 fusion of C5 and C6 and the first MIR showed that C5 and C6 showing the worse of my injured neck and it was hopeful that the less injured C3, C4, and C7, T1 and T2. In which, C5 and C6 was fussed by Doctor PS who used Medtronic Sofamor Danek’s product. A year later C4 now has a spur growing into C5 fusion this caused another surgery in 2007 Doctor RR removed the C5 and C6 fusing and found that C7 and T1 or C8 had worsen and again using Medtronic Sofamor in this fusion of C4-C8 removing spur at C5, fixing that fusion which produced a failed C7 Medtronic Sofamor product. The pain never left me after the 2000, and 2007 fusion surgery which caused bone growth at C3 a large spur growing into C4 has not been corrected, the pain from this spur along with my choking when I eat food or drink liquates in that I now have narrowing from C4-T2. In addition to in 2007 Doctor TK thru testing of my blood shows a low active Thyroid so now I am not only in pain I am suffering from the Thyroids not producing the correct low levels thyroid. Which could not be correct with meds another surgery was required in 2010; the testing of the Thyroid showed that it was bloody with white pose with round circle which lineup at the site of Medtronic Sofamor Danek’s screws the spots on the Thyroid gland was painful in which it was a slow process with OWCP not paying for this cause and effect. Dr. AA removes the Thyroid Gland which sets on top of C5 and C6. DR. AA opened his surgery at the same site as Doctor RR the 2007 surgery at C4-T1 caused the removal of my Thyroid which effect is to medication for my thyroid med’s for life. This isn’t the less of cause and affects the thyroid gland and caused a great deal pain before and after surgery. Doctor R, a pain specialist installed a pain stimulator implanted in 2011 a Medtronic Sofamor stimulator product which has some problems as well. This 2012 yet another Medtronic Sofamor bone graft surgery by Dr. RR using this product this was act C6 and C7 at the lumbar long after FDA as issued there waning. On of the biggest affects is that I need to have a new set of eyes the doctor that implanted Medtronic Sofamor product is still the treating Physician he is leading me down the wrong path my last visit to his office he tells me that I have and imbalance and need to see an neurologist I had to thank for a minute his is a neurologist surgery and one of my office visit I was sent to see a Psychologist. I have excepted his advance because I have a real heavy set of heath problems. One problems is that ever Physician that I attempt to set up an appointment with the declined me service stating a conflict of increase I looked a physician from over 100 miles away from Dr RR this is was I found is that birds of the faller all flack together they all belong to a medical group they guard them against how can you get will if bad doctors stick together and they support what Medtronic Sofamor in fact the or the part owners of this company. I have found that they or circling there wagons. At this point I am not being treated by my doctor that has treated me over the years.

  41. I had fusion surgery at L5-S1 in Oct 2011 and in July 2012, I stood up from a chair and then heard and felt a pop in my lower back. An hour later I was in so much pain I could hardly walk. Had an MRI done with inconclusive results. Then had a Myelogram which revealed the rods had become unstable and there may be problems with the screws. I asked the neurosurgeon what could have cause this but I got no answer. Now I have to have another suergery to remove the rods (defective?) Since the fusion appears complete. I am going to ask for the removed hardware for possible legal use. Others might want to do the same.

  42. I had surgery in 2006 with fusion and one of my screws are loose and tilted in an unusual direction. When I saw my surgeion due to horrible pain. I was told there was nothing he could do for me. Go get epideral injections for the pain, and file for Social security. I was dismissed and was told if I have any other issues in the future he would see me then. Other wise I need not come back in again. I am not sure who to see or where to go. I am in pain all the time and have spasms where I almost fall and have fallen numerous on occasions my back pops all the time and I have to use a cane for stability. I live in a very small town and I feel like I am being dismissed. Would love to know where to go. Now I can’t work any longer and had to apply for social security. Its very difficult when you know your way to young to be like this.

  43. Wow….I am so sad for all the pain all of US have been through! No one can possibly understand what chronic pain is like and how it robs us of the life (a FULL life) we once had. I too, had fusion L5-S1 on Aug 2011 and felt good for about 3 weeks (after initial healing of course.) I too, went to physical therapy and seemed to never see the improvements I held MYSELF too. I kept feeling the Leg pain (speading to both sides as well) and it kept getting worse and worse. I REMEMBER going back the FIRST time after surgery and looking at the xrays with the PA and him saying “I think the screw might be broken?” I was like “is it broken or isn’t it? You could tell he knew it might be, but wasn’t going to say anything. An xray nurse told me that SOMETIMES it will break in surgery but they have it so far in that they will leave it and hope for the best (which is what I think happened with me.) Finally a short while later I KNEW the right side was broken and pressing on my spinal cord because of the pain I felt and knowing my body the way I do. Bladder issues, SEVERE nerve pain ect. INDEED, additional xray showed it WAS BROKEN. I DEMANDED to get it out ASAP as I knew I was headed for serious damage if I didn’t. Same as all of you….the top of the screw head broke (Titanium) and I have heard that titanium shouldn’t break. Now a year later (and second surgery to remove the hardware this Feb 2012)) I am seeking an attorney (and searching for other stories like mine because I know this is NOT RIGHT. I am only 48 and should have NEVER had to go through a SECOND back surgery. Still in pain everyday and on the pain patch (which may be an option for some of you out there to ask for. I only recieved help from a Integrative Medicine/ M.D because they tend to understand the pain cycle more than just regular M.D’s so I encourage you to look for an integrative medicine doctor in your area online.) I can funtion better on the patch than on all the pills (atleast THINK a little clearer, but I still spend much of my days (A LOT OF THEM) laying flat because I don’t want to make the pain worse. I am so so sorry that this has happened to all of us and it is TIME that someone do something if this is a manufacterer defect. I personally am online looking for a product liability attorney right now, to see what options I have. I did get my screws back after removal and I have them in front of me in a bag. (Make sure you ask for them when you get the hardware removed) It took me 5 months to get the screws back and I had to call the hospital twice to follow up, so if you don’t get them back within a month….CALL THEM before they get lost!!!If you look at them under a microscope they have some numbers on them (which is probably the manufacterers lot.) I THINK mine is Medtronic and if you research Medtronics online you will find that they had not completely passed some of the trials on some of their products. IF ANY OF YOU have an attorney working on this OR you are filing a CLASS action please let me know. I too will post back if I have any luck on my end. This has GOT TO STOP so others don’t have to go through this.I am in California BTW. God bless all of you and know that YOU are NOT alone.

  44. To clarify the ABOVE…I meant Globus Medical not Medtronics.

  45. I can relate with you all as far as pain is concerned. I am a 34 y old female as a result of a recent car accident, i was left with a spinal fusion and surgery on both shoulders. I have a great amount of pain. But thankful to still be here for my 2 children. My spinal fusion on l4 l5. according to my dr was a success. And i do feel ok, well at least the leg pain is gone for good. So please do not be discouraged and follow your Drs advice for a speedy recovery. If your doctir say donot bend, lift or carry dont do it. I know is hard, in my case im blessed to have a wonderful mother that comes to from her home to mine every single morning before my husband leaves to work to take my baby to school. and promise to me that she will be here the whole 3 months as my neurosurgeon said, that this is the time that i need her the most and that is her pleasure to be here for me.. She is the best mother im truly blessed.

  46. well long story short..i had a spinal fusion and laminectomy April 3, 09. It failed. I have been through a lot of steriod injections, PT, meds, you name it i tried it. well the summer of 2012 i was referred to a surgeon that does Spinal Cord Implants and he did an xray on my back and showed me two broken titanium screws in my lower spine. so i immediately made a call to my spinal fusion surgeon. and i questioned him about the screws. he said he saw them and that he didnt tell me cause it didnt make a difference if he left them or fixed them. well after doing my research on xrays from post op..i found that they were broke within 3 months after surgery. i am looking to file a class action law suit against the manufacturer of the screws. if someone can contact me i would appreciate it. i want to get my back fixed but want to try and file this lawsuit first. i just had a spinal cord stimulator put in yest Jan 14, 2013. thank goodness i have a very helpful and loving husband who takes care of me. im 35 and disabled and will never work again.

  47. I am a spine surgeon. A lot of surgeons put in implants that the surgeon owns called a Physician Owned Distributor (POD). If your surgeon is using implants from a POD there is a good chance that your surgery done was more than needed to be done to the surgeon could make more money on your case. Simple greed. Many of these implants may be made in a foreign country, such as India, China, etc. The OIG is taking a very slow step at trying to investigate PODs. You should voice your opinion to the OIG if your surgeon uses a off label brand of implants. Find out if your implants were made by a legitimate company that can be found on the Internet. If you can’t find the company or implants on the Internet you may have had a physician who used a POD and made a lot of money on your implants. Go figure, doctors being greedy? I see it all the time and it sickens me.

  48. I had spinal fusion s1_ L4 on March 2012. “from the front” Three months later while bending to tie my shoe I felt a “pop” in my lower back. My X- Ray showed I had a broken screw. My pain had gotten to the point where I could no longer sit, stand or lay down without constantly searching for a better position. When I was able to have another CAT scan, my Dr. and his partner said I had to have another surgery because I did not fuse at all, my Dr. also said that if I wanted to sue the Manufacture he would write a letter for the attorney saying if the screw didn’t break so early on, my back would have fused more likely than not. I had my second surgery on Jan 2013 this time from the back, the first few weeks I felt pretty good, I have been suffering from a lot more headaches and migraines than usual the last migraine waking me up at 3 A.M. sending me into 8 hours of the worst nausea,vomiting,dry heaves and pain I have ever had, and during the dry heave stage felt a “pop” in my low back…I’m experiencing pain again..Dr. said the “pop” could have been stitches..I just had two major back surgery’ s within the last 10 Months…I don’t know if I can handle much more… not sure where to go to from here.

  49. I’m amazed at the Number of People who have problems with these Titanium Screws and Medtronic’s defective products ! I’ve tried to get Info and No One will respond……I’ve had 2 Fusions , the Screw broke on the 1st one. Therefore I had to have the second Fusion only to have them replace it with the same type of screw. I live in Pain everyday of my life and am trying not to take so many Pain meds.
    Why hasn’t the FDA Shut this Manufacturer down ?! Why can’t we find someone to help us ?

  50. If you’ve have any Medtronic Produce or hardware of anykind placed in your body that has broken or malfunctioning READ THIS and RESPOND to the Committee NOW !!!

    As reported last month by a U.S. Senate Finance Committee report raises new concerns about the safety and effectiveness of BMP-2 also known as bone morphogenetic protein-2, widely used in spinal fusion surgery.The Black Letter is an independent publication with Dr. Sam Wiesel, Professor of Orthopedic surgery at Georgetown University, as executive editor.

    The Senate Finance Committee report suggests that Medtronic inappropriately interfered with research into BMP-2, putting patients at risk by withholding important information on the adverse events related to use of the drug.

    “Without public disclosure of their roles, Medtronic marketing department employees collaborated with physician authors to edit–and in some cases, write–segments of published studies,” according to a statement from the Senate Finance Committee.

    Senator Max Baucus added, “Medtronic’s actions violate the trust patients have in their medical care. Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has.”

  51. Lori, suggest you read http://www.spine-health.com/treatment/spinal-fusion/lumbar-spine-fusion-degenerative-disc-disease This gives a good explanation as far when a lumbar surgery is indicated and when it isn’t. I question if your original surgery needed to be done? Ask your surgeon which implants were used. Were they regular major company implants? Unfortunately many times multilevel fusion operations patients have more post op pain than prior to surgery. Something your surgeon won’t share with you. There are many articles that can be found regarding conservative management of the spine and very few that advocate major fusion procedures.

  52. The more I read the more horrified and scared I become. I wish I had bee less trusting and researched spinal surgeries.I was to have a stabilization on L4-L5. The surgeon told me I had scaring and at my age (49) would not get better only worse. I had surgery on 03/01/11. The hospital stay was a nightmare, the surgeon tore he spinal cover and I had spinal fluid leak (the surgeon denied)Its in the OR report along with stating an intrabody cage was placed. The surgeon refused to tell me details of surgery and my follow up lased 4 months till I gave up my last appointment he avoided talking about my back but wanted to plan surgery on my neck! I made no complaint about my neck. The last two years has been constant pain, not being able to stand very long, walk very much,sit very long and last week the pain got so bad I had an x-ray that revealed a broke screw. And to top all this of, I have sought out three other surgeons and one pain specialist, All have told me in reviewing tests before and after there was no indication that I ever needed surgery, and the surgeon had not performed the surgery I thought. All tests only reveal 6 screws and no other hardware. Since, I have looked the surgeon up and he has numerous research papers published. I feel I am not the only patient he has done this to, but he is selective and chooses for his research.

  53. we are all in trouble. Yes i have broken screws also the pain. we all have to find one firm that will do a class action for us all. the only answer.if any of you find another way. Im with you.I will be going to have shots in my spine on tuesday 2-19-13

  54. I had four spinal fusion with bone graft off hip and six pedical screws I have hurt every day since and it has been 7 years and the pain just keeps getting worse anyone having same problem please contact me

  55. In 2009 I had major surgery for adult scoliosis. My fusion was with 2 DePuy titanium rods, 20 pedicle screws and bone grafts. In 2011, had a second back surgery due to the deterioration of 2 discs above original surgery also having instrumentation. The problem I am dealing with now is that one of the rods fractured at the L3-4 level. I thought titanium was virtually unbreakable. Now again, I am in so much pain from the base of my neck all the way down into my sacrum and have to go in for my 3rd back surgery.

  56. My 16 year old son underwent Posterior spinal fusion from T4-T11 using Medtronic 1/4 inch stainless steel implants with use of allograft bone graft for spine fusion. This was on 6/17/2011.
    It was a difficult recovery period for him, nevertheless he recovered with some pain from time to time.
    A week & 1/2 ago, he awoke with extreme pain in the surgical site and stated that “he felt like something from his back was coming through to his chest in front”
    Started taking Ibuprofen to get through the pain thinking he would feel better, only to be on bedrest for a whole 9 days & trying not to move as any movement was making the pain worse.
    I finally contacted his surgeon and made the appt. Xrays showed that 2 of the Medtronic screws had broken off and this is the reason he was having so much pain.
    I was shocked beyond words as this is supposed to be in his body for life. Dr. asked if he had a car accident, had fallen or done something to warrant this? He had not done anything, is not active nor in sports as guards his back and was only out of surgery 1 1/2 year.
    The surgeon has said that my son was the 4th kid with this issue. He would have to undergo another surgery to correct this problem and possibly have another fusion further down with a bridge of sorts.
    In the meantime this now 17 year old kid in 11th grade is unable to move much, has not been able to go to school, having constant pain nonstop. The surgeon said it was clearly a defective screws. My question is what is my recourse legally with a Manufacturer that is making defective surgical screws causing this to happen and having patients going back to undergo another serious surgery?
    Does anyone know what I can do?
    What type of Attorney do I see?
    Is there a Class action suit going on with this Company?
    We reside in Southern California
    All I want is for this company to make good on the stress and problems this has brought my son and other children as per the Surgeon saying he had 4 other cases.
    Please, someone let me know what my options are here, time is of the essence

  57. My broken screw was discovered at my first check up following surgery and fusion of C5&6, Doctor did not care and offered no relief or explanation. 18 years later still in constant pain, and no relief in sight.

  58. I’ve had two spine surgery’s both went well but now two years later one of the screws have broken. This is to many people with the same problems something needs to be done, MY SPINE is my MOBILITY. Without it what’s left of me?

  59. Im in the same situation as many of you. I have had two back fusions and within short periods of time screws broke, now I have a broken screw in my nerve and they cant remove the screw because if they do my cage will fall because a new screw cant be put in because of not enough bone growth. So now what , Im 39 and have three kids who I cant do alot with do to my immobitlity. Im in such misery it effects my everyday life and attitude. I also have drop foot now since this surgery. I know of four others in michigan that used the same surgeon and have had the same screws break. We all need to get together so this stops. I still owe money from my first surgery. I have medicare and I am permantly disabled thanks to all this. We at least need our medical paid for and help with living expences this is a nightmare!

  60. Tired of all this pain and broken screws lets get together and find help

  61. Y Has anyone had scar tissue and bone spurs developed around their implant? I didn’t get past two years before I was back on the table for that. I had noticed I had noticed I was shuffling right foot and had a lot of pain ,that is called drop foot. I haven’t hit one year yet already hurting again

  62. My husband has the exact situation as many and though we have insurance, it is $1100 per month with a 10K out of pocket. He has a broken screw and a loose screw and in on pain meds, still in constant pain. The Dr. just shrugs his shoulders and says it\\\\\\\’s rare but it happens. Would like to find folks who can still get involved in a class action suit and would be willing to engage in one.

  63. What are the odds of a Viper Pedicle Implant that was done on my lower back L4 last August 18, 2009, that left me paraplegic as to this days. Another neurosurgeon has finally remove 2 screw on one side of my spine because it was loose then replace it with stem cell (bone grafting). Because of how we are in trying to figure out what happen we have missed the timeline for the 2 1/2 yrs of Statute of Limitation in State of New York. When my husband retired as a NYSP we have never dream that he will also have to work full time on a minimum wage and also take care of me at home due to my disability. I have worked as Nurse since 1992 and resigned for work on 2003 because of my back pain. But in 2009 there was no avoiding the symptoms and that’s why I end up going to the same Neurosurgeon who perform my first back surgery on 1998. So for now, we are striving steps by steps in getting by with this financial crisis we’re on. I sometimes wish that I have died on that operating table to see my husband today struggle financially with no assistance of any kind. I wish there is one more option we could do just to see one more glimpse of hope with our present situation.

  64. I had a decompression and spinal fusion on my L4/L5. I had surgery on April 3,2009. Two of the screws on the bottom broke right in half. My surgeon NEVER told me!! I had a spinal cord stimulator put in in Aug 2012 but before I had that my new surgeon did an xray and found the screws. he asked if I knew they were broke. and I cried and said I had no idea. I went back and asked my original surgeon when they broke and he said he knew they were broke. he didn\’t see a point in telling me cause it wouldn\’t have changed anything. he said if he replaced them or took them out it wouldn\’t of taken my pain away. so here I sit as I type this w two broken screws in my spine. I am NOT the same woman I was before this surgery. I was only 31 when I had it. im 35 now. I regret it everyday!! it has not only affected me but has affected my family. they suffer cause I suffer. I was always independent and doing everything. I used to work like crazy to help take care of home and now I cant do that. I never imagined my life like this. I want to file a lawsuit but was told it has to be a class action lawsuit. well IM READY TO DO THAT NOW!! this is not fair. NOBODY should have to live in pain like I do. the devil couldn\’t even handle this pain. ITS NOT FAIR!! please contact me to get more detailed info. I have ALL of my drs records.

  65. I have 3 screws that broke and are causing excruciating pain. I contacted my surgeon and was told the screws are garbage. I refuse to take the pain meds due to COPD and liver compromisation due to the use of oxy and other perscribed meds. I was contacted by a law firm in Texas and they went after Medtronis for the Infuse implants that I had told them I did not have. They just sent me a letter stateing they were not going to persue this matter further, and to go to my surgeon to have them removed. I was under the knife for 12 hours to stabilize the 4 levels of my lumbar spine and know I have an extremely high chance of not makeing it out of the anestesia this time. I guess I am just supposed to go through life with the Metalosis the implants have caused and the feeling of going campimg and laying with a softball sized rock under my back just above the beltline. I am 56 and was told the complications will cause death in the next 1-2 years. Thanks a lot for modern medicine and the great job the FDA does to prevent bad drugs and products to be used on us. I now know what it feels like to be a Guinea Pig or lab rat. But other than that I am just freaking great.

  66. I did not realize there were so many with broken hardware. I had spinal reconstruction- L5 – T10 on 9/25/12 which was a 14 hr surgery. I have DDD, degenerative scoliosis and kyphosis. By the time I had this surgery, I had already had L4-5 , L5-s1 partial laminectomy/discectomy 4/16/09 and then within 5 months L3-4/ L4-5 collapsed and I had to have fusion with pedicle screws and plate on 9/3/09. I continued to get worse and slowly my spine became deformed and I was bent over so that I had to lift my head to see in front of me. Long story, but I was finally approved for social security disability 4/4/12 by adm law judge. Finally, I had insurance (medicare) and the spinal reconstruction was scheduled for 9/25/12 and within 5 months both rods broke and the screws were loose. I had to have the surgery redone Feb 9, 2013. Now, I have been having popping, creaking and a lot of pain. I know something is broke again, my surgeon ordered xrays but I think I will need to go to the ER before I have chance to go get the xrays. I don’t know what kind of screws/hardware I have but it should not have broken twice within 5 months of surgery. I am now so down about my health since I basically can’t do anything if activity is involved, I can’t enjoy my grandsons like I used to,

  67. I suffer from flat back syndrome . In February of 2013 I had a pedical removal osteotomy together with Smith Pedersen procedure and I have a fusion from T4 including the other Thoracic vertebrae, all of the Lumbars and anchored in the sacrum.
    The hardware was supplied by Depuy of Cobalt Cromium.
    I am facing revision surgery because both of the rods have broken.
    My surgeon tells me he has four other patients that have both rods have broken.
    Do you know of any other law suits against Depuy for defective rods?

  68. I had surgery on march of 2008 and 2 of my pedicel screws are broken I have 4 more that aren’t as of now! I am in extreme pain I just learn that the FDA Took the procedure I had off the market!

  69. After reading all these comments, I don’t feel so alone. I’ve been in the hospital so much like many of you. I want my old body back so badly. My last surgery was cervical with a plate and screws in front of neck after fusion. I have 2 titanium rods and a stimulator implanted to help my legs to walk. I have gained weight. Waaaay too much and want to know if there are exercises that are safe to do.
    By the way, two months after my flexible rods were implanted, I felt a snap in my back. One rod had gent to a near c shape with the screws hanging in there. My doctor took X-rays and was planning on going in to fix it, but 1 week later I felt that snap again and called him. By the grace of God the rod had snapped back in place with the screws intact. I’m like most. I as super active now I can’t do much at all. 10 min then rest etc . .
    ANY IDEAS on weight loss ?

  70. This has scared me and worries me.

  71. I see more and more people on here with broken hardware. THESE PEOPLE NEED TO BE STOPPED FROM HURTING OTHERS!! We have all lost our quality of life. We cant let others. Im so sorry for all of you. I wish some lawyers would do a class action lawsuit on this. This isnt fair to us. I went in having my spinal fusion thinking i would be ok after i recovered. But here i sit almost 5 years later. Im not able to do what i used to do. Please lawyers..reach out to us!!

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