Spinal Fusion Patients May Have Received Fake Medical Screws, Lawsuits Allege
Lawsuits suggest that hundreds of individuals may have undergone spinal fusion surgery in recent years where fraudulent or counterfeit parts could have been implanted in their bodies, potentially putting them at risk for serious complications caused by the sub-standard parts.
The Baltimore Sun reports that the University of Maryland’s Baltimore Washington Medical Center is sending letters to an estimated 250 spinal fusion patients, addressing concerns regarding potentially counterfeit parts that may have been used during certain procedures.
The hospital is one of about 17 nationwide affected by a recall of parts provided by the now-out-of-business Spinal Solutions, LLC., which may have intermingled with counterfeit parts that were never approved by the FDA as safe and effective, in what many describe as a massive health care scam.
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Learn MoreAt issue are parts manufactured by Spinal Solutions LLC, which were recalled in 2013 following an FDA warning letter that identified quality control problems. The FDA claimed that inadequate lower spine fusion parts could break, might be inadequately sterilized or move out of position.
Spinal Solutions went out of business after the recall. However, according to a recent lawsuit filed against the California-based company, many hospitals not only received parts that were of low quality, but that they may have actually involved counterfeit parts intentionally interspersed with real parts as part of a fraud scheme.
Among allegations raised in the claims are that a surgeon at University of Maryland’s Baltimore Washington Medical Center entered into an agreement with the company to use the products during surgery and was paid $458,962 in return for implanting them in patients. A number of other surgeons nationwide face similar allegations as part of a lawsuit filed by insurers.
The lawsuit was actually filed in February, but remained sealed for months. The complaint covers a period spanning from 2007 to 2012.
According to allegations raised in the complaint, the parts were co-mingled with real ones and would be extremely hard to detect. However, if they fail, patients could experience spinal fusion surgery complications that could result in injuries and require additional surgeries.
That lawsuit isn’t the first of its kind against Spinal Solutions or those associated with it. Suspicions were originally raised in 2009, when some parts suppliers, who had their parts distributed through Spinal Solutions, suspected the company was making knock-off versions of its parts, and pocketing the proceeds.
Those allegations were highlighted in a lawsuit filed in California in 2012, in which suppliers said they found clones of their products made with substandard materials, with fake laser-etching, counterfeit logos and poor screw alignments that could affect patients in numerous ways.
The issue has raised questions about how hospitals are informed about potentially defective or counterfeit parts, as it appears the fake Spinal Solutions hardware was used for some time. It also raises questions about the spread of counterfeit medical parts in the supply chain, with the World Health Organization indicating that as much as 8% of medical devices may be fake, though most of those devices are likely used in low-risk procedures.
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15 Comments
BARBARAJanuary 3, 2023 at 7:33 pm
Where do I begin to find out if I have a recalled item in my C5-6 neck fusion. It was done in 2012. The doctor soon retired and moved away. I live in a very small town that loves to keep secrets. My sister in law has this faulty hardware in her neck and hip. She only received the recall notice by accident...the letter was supposed to be sent to her surgeon and was sent to her by accident. The hosp[Show More]Where do I begin to find out if I have a recalled item in my C5-6 neck fusion. It was done in 2012. The doctor soon retired and moved away. I live in a very small town that loves to keep secrets. My sister in law has this faulty hardware in her neck and hip. She only received the recall notice by accident...the letter was supposed to be sent to her surgeon and was sent to her by accident. The hospital she used has since literally changed her chart to show something different than when she actually had the procedure. She only knew this much due to her being diligent about printing things out as they come (the only reason she has proof). I do not have proof, did not use the same doctor or hospital and do not know how to figure this out. I have multiple health issues that only get worse and am currently being seen by Mayo to hopefully get a diagnosis or more (perhaps some could link to faulty hardware?....hoping not). Thank you for your time.
WALLACEDecember 17, 2021 at 11:48 am
i believe i recieved counterfeit hardware as the doctor who did repairs gave it to me and suggested i hold onto it
ThomasOctober 27, 2021 at 1:46 pm
Failed fusion and decompression....Doctor Curry at St.Peters medical group left town. I am now about to go under my 3rd revision surgery.
SherryOctober 2, 2020 at 11:45 pm
My 2010 lumbar fusion surgery was done in Riverside County, CA. Was told by surgeon ahead of time that I would need a second more complicated surgery later. That didn't happen as I lost my private medical insurance after a divorce. Had no insurance until 2015. I had saved lots of my medical records then went to two surgeons to help me with my ongoing back problems. They said that they couldn't hel[Show More]My 2010 lumbar fusion surgery was done in Riverside County, CA. Was told by surgeon ahead of time that I would need a second more complicated surgery later. That didn't happen as I lost my private medical insurance after a divorce. Had no insurance until 2015. I had saved lots of my medical records then went to two surgeons to help me with my ongoing back problems. They said that they couldn't help me. Said that to fix me they would end up turning me into a robot and couldn't do that. Told to just take pain meds the rest of my life. I dont know why two doctors wouldn't touch me. I dont know if I have the counterfeit metal in me still and if I do. Is it causing my body to decline? I live near the offices of spinal solutions and orthopedic alliance in riverside. Ca. I never received a recall notice from those places or the riverside hospital where my lumbar fusion was done. Does that mean that I dont have counterfeit metal in me??Did anybody get those recall notices?? Maybe I will soon find out.?? I have been scheduled for a lumbar fusion to be done all the way to S1 since 2019. They seem pretty anxious to remove the existing hardware. I never asked why. Now I want to ask before I get dug into.l thought about asking them to save me the hardware in a jar as a souvenir. How common is this counterfeit stuff? I read that my hospital is on the recall list. I need info. I have lots of doctors and surgeons to go to now to get my body fixed. Thanks for listening . Thanks for any input. My best wishes to all of you.
WallaceMarch 3, 2020 at 9:48 pm
How does one find out if possible bad hardware was used in vermont 2009
DianaOctober 12, 2019 at 7:25 pm
Were you able to find out the hospitals and doctors that bought and used the fake hardware from Spinal Solutions? Any help would be appreciated.
AngelJune 25, 2019 at 11:27 pm
Spinal fusion 2011 (failed) staff infection 7 weeks post op. Learned about a month ago i have a cracked screw in my back. I now am in need of another fusion on L3-L-4. This has been the worst pain of my like. And because of it all i am now legally disabled....
AJune 22, 2019 at 1:16 am
How do I go about finding out it I have these counterfeit parts in my fusion? My 2010 L4/L5/S1 done in Houston, initially appeared remarkable. Two weeks later horrific pain& swelling resulted in 5hrs of emergency surgery & 2 units of blood to clean out infection. Staph, Strep A throughout my back w/ no explanation. Hickman installed & vancomycin 2x day for 40 days. I read some of the Spinal Soluti[Show More]How do I go about finding out it I have these counterfeit parts in my fusion? My 2010 L4/L5/S1 done in Houston, initially appeared remarkable. Two weeks later horrific pain& swelling resulted in 5hrs of emergency surgery & 2 units of blood to clean out infection. Staph, Strep A throughout my back w/ no explanation. Hickman installed & vancomycin 2x day for 40 days. I read some of the Spinal Solutions hardware went to TX also. I would like to know. Thanks, Anna
SuzanneJune 22, 2019 at 1:07 am
I had spinal fusion as part of a surgery, my 9th, in 2012 am wondering how I can find out if the hospital bought screws from spinal solutions. Anyone know how to find out which hospitals bought screws from this company??
JarenJune 22, 2019 at 12:51 am
I had spinal fusion surgery in February 2010. Would i have any of these screws in my back???
betsyOctober 11, 2016 at 7:52 pm
Screw broke off device in my lower back extreme pain another surgery is needed to fix scared to do it now because of what happened the first time
LisaSeptember 25, 2016 at 10:35 pm
Hello I'm sorry to hear that you all are having problems too with your surgeries. I am 37 years old now and completely disabled. The pain is out of this world. I now have to have another surgery. I have found out that the Dr lied to me originally telling me I had a tumor and didn't to get money from the insurance. I'm so mad and let down. And then find out I have bad parts that the drs worked out [Show More]Hello I'm sorry to hear that you all are having problems too with your surgeries. I am 37 years old now and completely disabled. The pain is out of this world. I now have to have another surgery. I have found out that the Dr lied to me originally telling me I had a tumor and didn't to get money from the insurance. I'm so mad and let down. And then find out I have bad parts that the drs worked out a deal possibly with the insurance company and the supplier to get a kickback. Yes I said a kickback!!!!! The spine industry is a ola for some bad drs to make MONEY. But there are some good Dr's out there. Which I have found. I have been in contact with a Dr in California who has been communicating to me and also has been trying to get the government to see that these things are happening. The DR's have ruined MY LIFE COMPLETELY!!!!!!!! THEY REALLY HAVE!!!!!! DO YOUR RESEARCH IF YOU THINK THIS MAY HAVE HAPPENED TO YOU AND HELP ME BRING THIS STUFF TO LIGHT!!!!!!!! LETS STAND UP BEFORE THEY RUIN THE LIFES OF OTHERS!!!!!!!! GOD BLESS YOU. You all are in my prayers I know it's hard to have a good attitude and stuff when your in pain daily but just know there are others who are going threw it too and understand. I do try and remember to take things one day at a time. God Bless. Lisa
SharonMay 17, 2016 at 7:41 pm
Need more info
richardDecember 17, 2015 at 9:57 pm
still having problems after surgery in aug 2014
johnJuly 21, 2015 at 10:58 am
I've had 15 back surgeries n broken every device that had been placed in me . Mon my last surgery , I contracted staph strep n msr8 or merssa . All existing hardware had to be removed . I spent 15 yrs in the hospital .My last surgery I spent a total in all of 72 days 5 or 6 in an induced coma , half a dozen n ICU died twice n yes I'm 9 inch shorter than my original hieght. If diabled n have been s[Show More]I've had 15 back surgeries n broken every device that had been placed in me . Mon my last surgery , I contracted staph strep n msr8 or merssa . All existing hardware had to be removed . I spent 15 yrs in the hospital .My last surgery I spent a total in all of 72 days 5 or 6 in an induced coma , half a dozen n ICU died twice n yes I'm 9 inch shorter than my original hieght. If diabled n have been since 03. Yes it imbarrasing to be humped over n crippled an try to act like a normal human being. It's been a struggle but I've learned different ways to do things differntly. Or I could give up n die, nut it's not in Gods plan for me yet.