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New Pedicle Screw Spinal Implants Need Further Safety Studies: FDA

  • Written by: AboutLawsuits
  • 81 Comments

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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81 comments

  1. Scott Reply

    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.

  2. MARY Reply

    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.

  3. Ronnie Reply

    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

  4. tracy Reply

    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

  5. Carol Reply

    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.

  6. Taleah Reply

    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

  7. Mary Reply

    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.

  8. fred Reply

    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?

  9. Dana Reply

    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!

  10. Dana Reply

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

  11. robbie Reply

    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

  12. Linda Reply

    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.

  13. Rosa Reply

    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.

  14. Misty Reply

    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.

  15. scott Reply

    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.

  16. valerie Reply

    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,

  17. Richard Reply

    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?

  18. Vicky Reply

    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!

  19. VickiKay Reply

    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 ?

  20. VickiKay Reply

    This has scared me and worries me.

  21. Misty Reply

    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!!

  22. Misty Reply

    I was wanting to know if all of you on here that have broken screws would get a hold of me on facebook. you can look me up Misty Tom Lawrence. If you cant add me as a friend send me a message. I am wanting to get a class action lawsuit together. we need justice for ourselves!! this isnt fair. I will be having my broken fusion fixed June 2014. They will be leaving the broken part of the screw in my spine due to that its too risky to take it out. The new screws will go in my S1. Im so upset about having to go through this again!! Please get a hold of me..thanks

  23. JOSEPH Reply

    Like several before me I have read almost everyone of these comments about broken rods and screws. My first back surgery in Jan 2012 resulting in two titanium rods with about 20 screws went well. 9 months later while reaching for an empty box I felt a crunch, followed by severe pain. An xray revealed I had broken one of the rods. Additional surgery in Nov 2012 included a splice of the broken section.

    Unfortunately I started to have excruciating pain. For the next 5-6 months the only way I could try to sleep was in my recliner. I could not lay flat on either my back or stomach.

    A third surgery was required in July 2013 determined that screws had come loose and were causing lots of pain. The screws were tightened and an additional extension was added in the T section. The surgery was a success and I was walking with minimal pain in 2 days. My wife almost lost me 3 times from complications.

    I am very thankful for all the attention that I received from dedicated nurses and doctors for the next 8 days.

    I have tried to contact lawyers to investigate either and individual law suit or a class action law suit. To date 3 lawyers have denied my request.

    My research has revealed that Medtronics has spent MILLIONS of dollars fighting law suits.

  24. PRC Reply

    So reading all these comments I wonder are there any good cages, screws & rod for one’s spine?

  25. quentin Reply

    Have had to spine surgeries about to have revision spine surgery done due to pseudoarthrosis ( failed spine surgery) the neurosurgeon did a real poor job on my spine surgeries been livig with intolerable pain taking pain meds but they really don’t help dr said I had swollen joints loose joint loose hardware and compression of nerves and now because of the first doctors mistakes I have to get all the hardware removed from L5-S1 level and he is going to extend the fusion from L4-L5-S1 dont understand how one surgery turns into three surgeries the damage is done my new spine doctor said that my spine is currently a mess wow really worried about going through with this third surgery have lost the use of my left leg and now im concerned about losing the use of another leg or a arm or all four confused and in pain anyone have any suggestions all ears

  26. Kris Reply

    I had a cervical disc replacement and fusion three years ago. I also have broken screws. My neurosurgeon moved off two months after my surgery and pawned me off on a pain managment dr. I got to the point to where I could not work any longer and lost my good insurance so pain managment didn’t want to treat me anymore. I had to fall on my last resort, the VA. after a year of waiting to see a doctor, they took x-rays mri and cats and found my screws were broke. The VA neurosurgeon said, “I’m scared to touch it.” So now I am going to another doctor this week outside the VA. Surely there is a lawsuite somewhere in here.

  27. Pattie Reply

    I am 46 and have had 3 spinal surgeries and am scheduled for my 4th in late July. When doing the x-rays for my 4th surgery last fall my surgeon realized that my screw had broken completely in two. I have a lawyer working on my disability case as I have DDD and softening bones but am wondering if I should have a lawyer look into the manufacturer of the screws and see if there around grounds for a lawsuit. Any feedback would be appreciated!! Never a day without some kind of pain! My third surgery was in March of this year and was a redo of my previous cervical surgery where they did two openings in the 9 hour surgery. One in front of my neck and one long incision in the back and installed multiple plates and 18 screws. I am still recuperating from it. Every time they fix and stabilize one area of my spine with titanium the disc above or below what was fixed blows out on me and I currently have bone rubbing bone in my lumbar area!

  28. Anna Reply

    I’ve had 4 back surgeries , since my last on in 2010 I’ve had a screw break into causing me pain clumbness ,nunbess, and other symptoms . Is there any law suits for a tityium screw breakage and what can it do to my body? My dr. Has only suggested a hardware pain block test and my insurance will not pay for it .

  29. Mary Reply

    I had my first surgery because I had a blown disc. I was also born with an extra vertabrea with one side fused..so pain pain pain back in 6 mo. I had my low lumbar fused with simmons plating systems…i did everything I was told my husband and kids took care of me…I WANTED TO BE WELL and I did what I could. But, I woke up one morning and the bed was wet. it was soaked from my padding and through. Went to the ER..since the fluid drained out when I got to the ER it was dry. I was sent home. I saw my doctor 3 days later and i kept telling them it was draining…well, my doctor came to take the stitches and he says mary, your draining all over the table..i said I had been calling. so, BOOM surgery the next day they got 16 oz of blood and water. I was mad they wouldnt listen to me. so I go home . well i did not feel real well…i was running a fever of 102 with tylenol. Of corse I was ignored. NOW I was crying my daughter looked and puss was coming through my stitches. I knew they were going to do a central line in my neck that alone freaked me out. So much crying. I made arrangements to go back to the hospital. I was sitting on the toilet when I got up my incision opened up blood water everywhere all my husband wouldnt let me look down it was bad. We called an ambulance. this time my dr. met us there. It was awful. He took the rest of my stitches out and it was all infected it was packed and planned surgery the next day. Taking those stitches out of an infected wound was excreationing god it was bad. well the blood work came back i had a staph infection.you wanna see some drs. hop…and my infection count was high. do we leave the hardware in or out! staph cant be killed on the hardware. GOD I was so burned out, depressed, scared..and I knew that central line was coming. i didnt want another surgery that would be to much…toooo much. So my doc packed it and I was dumped into a salt water tank twice a day to draw out the infection. and it actually worked…it healed from the inside out. its two weeks later and time to go home…except this time I had nursing care I had a nurse over every 8 hours to tend to that central line and my medications..I was still in pain a yr. later. but, my doctor refused surgery. so I went from dr. to dr. to dr. noone would touch the hardware. I wanted it out. 19 years that went on…suffering in silence.
    I moved to CA. I had no problem. Surgeon said we’ll investgate it. My hardware was broken. so they took it all out and refused it with hardware. I was so disappointed about the hardware I wanted it out. So, 6 months later a basket case he says lets take ‘em out….OMG… You know what they took them out I AM IN NO PAIN…I havent had a tylenol in a yr. My heart weeps for you if your still suffering. It has been a long scarey life. You miss so much. Your depressed…ALL I can say is dont give up, don’t give up all that and disability refused me can you believe it…I AM VERY interested in a class action suit ….WE DESERVE ONE… and the drs. should quit giving false hope using the glorys of pedicle screw implants..they manipulate us..and we are so sick we give in…its not right. I kept my hardware. someday I may need it. STAY STRONG you’re gonna make it.

  30. Mary A. Reply

    I had lumbar/sacral surgery November 2009. I did great. I was walking a mile or more afterwards.
    Approximately July 2011 I began having right groin pain which was severe. I thought it was from my hip. Gradually my right leg stared becoming numb so surgery was necessary. In November 2011 Lumbar 2 and 3 were fused to the previous lumbar. Not to mention, a small nick in the spinal dura, I was told by the surgeon. I was , also informed it had a blood patch. I found out later the surgeon did the “last ditch effort” by placing a postage stamp size patch over the dura to start with.
    Doctors do not like to listen to patients. Number one: I kept telling them the hardware in my back was hurting. If it made me bionic I could take it. i tried to throw some humor in. Number two : something else was wrong.. My side kept swelling. I sleep on my left side. I never got headaches. The surgeon’s PA told me to go to my medical MD who told me to go back to the surgeon. i finally begged ( and I mean begged ) the surgeon’s PA to order a CT scan and send me to whatever doctor I needed to go to. he ordered it. I had a massive CSF leak and had to return to surgery January 2012. I had only left side pain and swelling ( no headaches ). End of that for now.
    I was sent to a pain center for injections to control the constant pain i was in. i complained to everyone about the hardware in my back hurting and the pain that “would me to my knees ” in my mid back.
    I , later, learned it was Lumbar 1 with a pedicle screw in it and it was fractured ( unknown when ). Right !
    The pain doctor , while giving me an injection , approximately 4 -5 months post op happened to state there was a screw out. Next time, there was another screw out and how did the surgeon bend the bar like that. I don’t remember exactly when he showed me the scan of L1 with the screw in it and the fracture. I am not certain but probably fall of 2012. I returned to the orthopedic surgeon’s office , saw the PA and requested the hardware be removed as it was so painful. He waited about a month before ordering a CT scan which showed I was leaking from the spinal dura . I decided to call a neuologist I had been to to seek a neurosurgeon. it just happened there was a new one seeing patients at her office every Tuesday. I wanted honest answers . I was told the spinal dura was not fixable. He said he could patch it to death and it would still leak. As for removing the hardware I was informed I would need reconstruction surgery to repair my back. I would be under anesthesia 10-12 hours. I was in shock. I was 67 years old then. How could I survive that surgery is what I was thinking. He suggested a spinal cord stimulator. The first one was placed by the pain center doctor. I fell and the leads came loose. The second one was done by the neurosurgeon April 2013. I was under anesthesia 4 hours and he almost gave up. When it was turned on by the representatives my greatest fear happened ( which I was told was highly unlikely ). I was shocked ( as when fluid and electricity connect ) as I was having a spinal fluid leak.
    I failed to mention I had cervical neck surgery with implant in May of 2009 and have been informed that surgery has failed as well.
    Now , I have felt the hardware or something slip down on the right. I am having right groin pain and hip pain. My hip Xrays show a little arthritis. Getting in and out of bed and automobiles is extremely painful as the hardware moves and pinches I feel like I have thinks poking in different parts of my back.
    A friend told me about a commercial on tv regarding a class action case regarding screws coming out and hardware flopping around. I have several friends watching for the number and my aquatic physical therapist obtaining my medical records. The number starts with 877…. For those of you with failed neck implants if you had the ” INFUSE” there are class actions for that one as well. I have to find out what I had placed for the neck and back

  31. frank Reply

    TITAN SPINE now offers a warrantee on their hardware—-but the main thing that this has revealed is that their hardware is permanent———so now that tells me the only reason the others indicated that their hardware was to be removed was to cover up the expense of the 2nd surgery which they call revision. All prior patient have been betrayed concerning law suits over defective hardware and removal. I hope the FDA makes a quick change about this——————————–

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