Hello - Has anyone on this board been a subject in a clinical trial for Stryker Spine Cervicore Interverterbral Disc - one level total disc replacement? I am looking for other subjects who were recruited into this trial that was sponsored by Stryker Spine for their IDE clinical trial of the CerviCore disc implant. I was a subject in 2008 and have had substantial adverse events that the PI has never reported to the sponsor or FDA. My cervical condition is worse post surgery and the neck - bilateral arm pain is unbearable. I have had a post surgery MRI, EMG and Myelogram CTscan that I had to pay for out of pocket that shows foraminal stenosis (bilateral) at the implanted disc site (C5-C6) and foraminal stenosis at adjacent disc, C4-C5 - right side, multi-level let side facet joint arthrosis and uncovertebral disease, reversal of lordosis - kyphosis, multi-level degenerative discs, possible left greater than right foraminal narrowing at C6-7 & left sided hypertrophy at C7-T1 and something showed up on the mylegram that said that the nerve roots at the disc implant site are shortened and blunted at the nerve root sleeve.
The PI who recruited me into this clinical trial refused to listen to my early onset of complaints (within 6 to 7 months) post surgery. He told me that my complaints were due to "old age" and refused to do any testing (as per the consent form) for post surgery complications, other than to take Xrays and state that the "prothesis was in position". I had to go to a neurosurgeon to get presriptions for the MRI/EMG and my pain clinic physician finally decided to order the myelogram/CTscan after a year of my chronic complaints about neck and arm pain that has rendered me totally disabled.
I saw that there was another member on this board who was in phase one of the trial (I was told that I was in phase two). The member goes by "painstaken" and I was wondering if this member is still on this board -- as I think we need to compare notes.
The consent form that I signed does not mention anything about the risk of foraminal stenosis or reversal of lordosis-kyphosis complications post surgery. The neurosurgeon who ordered the MRI etc said that I had to return to the PI (prinicple investigator) and show him the film she copied that show the adjacent disc stenosis. When I returned to the PI - he denied the existence of stenosis - and did not report anything to the sponsor or FDA. My MRI prior to the surgery showed only a herniated disc w/ bilateral stenosis at C5-C6. The PI said I had to have a myelogram to collaborate the MRI but refused to order it and have Stryker pay for it pursuant to the terms of the consent form.
I finally wrote a letter to Stryker, the IRB and the PI and his research nurse, and have heard nothing back from them. I had to contact the FDA and file a complaint to initiate an investigation as to why the priniciple investigator is not complying with the FDA and reporting unaticipated and adverse events post surgery.
If anyone has any answers or can tell me what I am supposed to do to get this thing removed from my neck, have the two or three teir fusion and correct the reversal of lordosis-kyphosis please let me know as soon as you read this. I cannot get another neuro or orthopaedic surgeon to look into this as they do NOT WANT TO GET INVOLVED in another surgeon's clinical trial mess up. My patient rights as a clinical trial subject have been criminally violated and I have no idea if I am the only subject of this clinical trial that was abused by the PI or if this is a pattern with all of the Stryker spine PIs who willfully refuse to investigate post surgery complaints of the subjects and report the adverse events/complications to the sponsor and FDA as is required by the CFR regulations for high risk medical device IDE surgeries.
The PI who recruited me into this clinical trial refused to listen to my early onset of complaints (within 6 to 7 months) post surgery. He told me that my complaints were due to "old age" and refused to do any testing (as per the consent form) for post surgery complications, other than to take Xrays and state that the "prothesis was in position". I had to go to a neurosurgeon to get presriptions for the MRI/EMG and my pain clinic physician finally decided to order the myelogram/CTscan after a year of my chronic complaints about neck and arm pain that has rendered me totally disabled.
I saw that there was another member on this board who was in phase one of the trial (I was told that I was in phase two). The member goes by "painstaken" and I was wondering if this member is still on this board -- as I think we need to compare notes.
The consent form that I signed does not mention anything about the risk of foraminal stenosis or reversal of lordosis-kyphosis complications post surgery. The neurosurgeon who ordered the MRI etc said that I had to return to the PI (prinicple investigator) and show him the film she copied that show the adjacent disc stenosis. When I returned to the PI - he denied the existence of stenosis - and did not report anything to the sponsor or FDA. My MRI prior to the surgery showed only a herniated disc w/ bilateral stenosis at C5-C6. The PI said I had to have a myelogram to collaborate the MRI but refused to order it and have Stryker pay for it pursuant to the terms of the consent form.
I finally wrote a letter to Stryker, the IRB and the PI and his research nurse, and have heard nothing back from them. I had to contact the FDA and file a complaint to initiate an investigation as to why the priniciple investigator is not complying with the FDA and reporting unaticipated and adverse events post surgery.
If anyone has any answers or can tell me what I am supposed to do to get this thing removed from my neck, have the two or three teir fusion and correct the reversal of lordosis-kyphosis please let me know as soon as you read this. I cannot get another neuro or orthopaedic surgeon to look into this as they do NOT WANT TO GET INVOLVED in another surgeon's clinical trial mess up. My patient rights as a clinical trial subject have been criminally violated and I have no idea if I am the only subject of this clinical trial that was abused by the PI or if this is a pattern with all of the Stryker spine PIs who willfully refuse to investigate post surgery complaints of the subjects and report the adverse events/complications to the sponsor and FDA as is required by the CFR regulations for high risk medical device IDE surgeries.
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philomena.55 The consent form that I signed does not mention anything about the risk of foraminal stenosis or reversal of lordosis-kyphosis complications post surgery. The neurosurgeon who ordered the MRI etc said that I had to return to the PI (prinicple investigator) and show him the film she copied that show the adjacent disc stenosis. When I returned to the PI - he denied the existence of stenosis - and did not report anything to the sponsor or FDA. My MRI prior to the surgery showed only a herniated disc w/ moderate to severe left side stenosis at C5-C6. The PI said I had to have a myelogram to collaborate the MRI but refused to order it and have Stryker pay for it pursuant to the terms of the consent form. [/quote wrote:
This is a correction by the author. I realized that I made a mistake regarding the pre surgery MRI. I had left side moderate to severe stenoses prior to the surgery. The recent myelogram and CT scan now indicates that I have bilateral stenosis at C5-C6 with nerve sleeve root blunting and shortening. Hence, the stenosis was never adequately treated before the implantation and now the stenosis has either returned or was never removed before replacing the cervicore disk.
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Hello,
Sorry about your pain. Yes, cervicore has ruined my life also. I wish I could warn the world about the evil disc and the butchers that implant them. I begged for two years for them to remove it. They called me "over dramatic" because I"m a woman and I was in so much pain and couldn't swallow. I felt like I was being strangled. When they removed it, they found that scar tissue had formed and was pressing on the esophogus, trachea and spinal cord. Of course, they minimized this information. They didn't tell me that they also had to pry cervicore out and in doing so took out 3/4 of my upper c5 and c6, so the 2nd surgery fusion failed!!!
I wish I had any advice but due to the extensive damage from the cervicore, the 3rd surgery failed as well because my vertabrae can not
withold any weight. I was 37 and a track coach before this. I can barely get through the day and have not run in over 3 years.
I understand your frustration, I went through every surgeon that would see me in Pittsburgh and they all said they couldn't (wouldn't ) help me. My only advice is go to a renowned clinic near you and get a complex cervical reconstruction orthopedic surgeon.. I am now at cleveland clinc in ohio and my 4th surgery in Nov. 1st. He was appalled at the damage from one disc.. but cant find an attorney to take on stryker or the famous surgeon that implanted it and played God...
Please keep me updated.. It is so unfair to suffer at the hands of arrogant surgeons and scrupulous pharm. corporations... Good Luck - Melinda
Sorry about your pain. Yes, cervicore has ruined my life also. I wish I could warn the world about the evil disc and the butchers that implant them. I begged for two years for them to remove it. They called me "over dramatic" because I"m a woman and I was in so much pain and couldn't swallow. I felt like I was being strangled. When they removed it, they found that scar tissue had formed and was pressing on the esophogus, trachea and spinal cord. Of course, they minimized this information. They didn't tell me that they also had to pry cervicore out and in doing so took out 3/4 of my upper c5 and c6, so the 2nd surgery fusion failed!!!
I wish I had any advice but due to the extensive damage from the cervicore, the 3rd surgery failed as well because my vertabrae can not
withold any weight. I was 37 and a track coach before this. I can barely get through the day and have not run in over 3 years.
I understand your frustration, I went through every surgeon that would see me in Pittsburgh and they all said they couldn't (wouldn't ) help me. My only advice is go to a renowned clinic near you and get a complex cervical reconstruction orthopedic surgeon.. I am now at cleveland clinc in ohio and my 4th surgery in Nov. 1st. He was appalled at the damage from one disc.. but cant find an attorney to take on stryker or the famous surgeon that implanted it and played God...
Please keep me updated.. It is so unfair to suffer at the hands of arrogant surgeons and scrupulous pharm. corporations... Good Luck - Melinda
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Melinda,
We have a lot to discuss. I know of other CerviCore failers. Are you in Pittsburgh? My husband's company is HQ'd there. I have some answers for you and we may be able to get something done legal wise. I have already contacted the FDA and there is an investigation into the clinical trial in place. Please let me know if you get this and I will try and find your direct email addy to get back with you. It is very important that we speak as soon as possible. It sounds as though you have had serious adverse events and I am wondering if your PI reported them to the FDA in a timely manner. I have tons of research that you may be interested in.
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We have a lot to discuss. I know of other CerviCore failers. Are you in Pittsburgh? My husband's company is HQ'd there. I have some answers for you and we may be able to get something done legal wise. I have already contacted the FDA and there is an investigation into the clinical trial in place. Please let me know if you get this and I will try and find your direct email addy to get back with you. It is very important that we speak as soon as possible. It sounds as though you have had serious adverse events and I am wondering if your PI reported them to the FDA in a timely manner. I have tons of research that you may be interested in.
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Go here and sign up - I am one of the moderaters.***edited by moderator*** web addresses not allowed My contact there is PAG.
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Hello again,
Yes, I am from Pittsburgh and I look forward to talking with you. I have to be up extremely early - struggling through teaching with tons of steroids in order to keep my med. benefits. Please email me and let me know when we can set up a time to talk. I'm usually home by 4.
My email is ***this post is edited by moderator *** *** private e-mails not allowed **
Please read our Terms of Use and my phone is *** private info removed ***. The last 3 and a half years have been a isolated nightmare, I hope we can find some answers.. Talk to you soon. Melinda
Yes, I am from Pittsburgh and I look forward to talking with you. I have to be up extremely early - struggling through teaching with tons of steroids in order to keep my med. benefits. Please email me and let me know when we can set up a time to talk. I'm usually home by 4.
My email is ***this post is edited by moderator *** *** private e-mails not allowed **
Please read our Terms of Use and my phone is *** private info removed ***. The last 3 and a half years have been a isolated nightmare, I hope we can find some answers.. Talk to you soon. Melinda
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Hi there, I had a c5 c6 cervicore stryker disk replacement done in December 2010. Felt good at first but now (8 months later)i am starting to feel some pins and needles in my neck. I am about to go back to my surgeon but I don't fully trust him. After reading through some of these letters I am starting to get a bit worried. If anyone has any updates on thier situation or advice for me in my situation, i would really appreciate it if you could let me know.
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Slippery, I posted my first response before realizing that you stated that your disc was implanted in December of 2010. I had the myelogram done in February of 2010 - some 10 months prior to your disc implant. Did your surgeon tell you that there were reported adverse events? Were you told that there was nickel in the device prior to consenting? Were you prescreened for metal sensitivity or allergies? Are you familiar with FDA Guidance to Industry recommendations for spinal metal on metal disc replacements requiring that you be tested for metal ion release? Did you know that this study has been in the "FDA Black Lock Box" for trials of devices not cleared or approved by the US FDA" since December 21, 2007? http://clinicaltrials.gov/ct2/show/NCT00588601?
My PI should have informed your PI about the findings in my Myelogram of the 8 tumors? I am shocked that he did not do this and allowed others to be implanted with the disc knowing that it caused tumors around the artificial disc. What state are you in? You need to consult an attorney - as you still may be able to get the competent medical attention you need before your statutes of limitations run on medical negligence by your surgeon. There is a lot of imformation out bout the dangers of these metal on metal devices causing metallosis and osteolysis -- and I know that Stryker surgeons are NOT going to tell you what is going on based on my and several other CerviCore subjects that I have spoken to at length. Stryker has a duty to protect your health and welfare and you have a lot to lose if you do not find out as soon as possible what is going on with your disc. I do not want to suggest any symptoms so I will not go into any specifics about mine now - but if you email me I will send you my images that you can show your surgeon and this might instigate your surgeon to order tests - i.e. myelogram and bone scan to make certain that you are not at risk for metallosis from the nickel in the disc. And you may still have time to get an attorney to enforce the terms of your consent form to make sure you don't have to pay for the imagining tests. I had to pay for mine -- as the PI I had would flat out not listen to my complaints -- but now that I know he expected to make millions from royalties after the disc was on the market -- it makes perfect sense - Greed outweighed his adhering to the ethical contract he signed with the FDA called an investigators agreement to protect your health and welfare first and foremost. Did you know that there are 3 different versions of the Cervicore disc on the internet? I have no idea which one was officially approved by the FDA for the IDE.
My PI should have informed your PI about the findings in my Myelogram of the 8 tumors? I am shocked that he did not do this and allowed others to be implanted with the disc knowing that it caused tumors around the artificial disc. What state are you in? You need to consult an attorney - as you still may be able to get the competent medical attention you need before your statutes of limitations run on medical negligence by your surgeon. There is a lot of imformation out bout the dangers of these metal on metal devices causing metallosis and osteolysis -- and I know that Stryker surgeons are NOT going to tell you what is going on based on my and several other CerviCore subjects that I have spoken to at length. Stryker has a duty to protect your health and welfare and you have a lot to lose if you do not find out as soon as possible what is going on with your disc. I do not want to suggest any symptoms so I will not go into any specifics about mine now - but if you email me I will send you my images that you can show your surgeon and this might instigate your surgeon to order tests - i.e. myelogram and bone scan to make certain that you are not at risk for metallosis from the nickel in the disc. And you may still have time to get an attorney to enforce the terms of your consent form to make sure you don't have to pay for the imagining tests. I had to pay for mine -- as the PI I had would flat out not listen to my complaints -- but now that I know he expected to make millions from royalties after the disc was on the market -- it makes perfect sense - Greed outweighed his adhering to the ethical contract he signed with the FDA called an investigators agreement to protect your health and welfare first and foremost. Did you know that there are 3 different versions of the Cervicore disc on the internet? I have no idea which one was officially approved by the FDA for the IDE.
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I had my Cervicore Implant in late 2006. Pain was lessened for a short time after surgery. It has never "felt" right. I have had sleeping problems and sharp pains when moving my neck ever since the surgery. I was told by the Surgeon that the surgery went perfectly, and that I just need to do more PT. After continued complaining, he told me that he thinks the pain is all in my head. He has, over the past 5 years since the surgery, suggested that I go see a Neurologist, a Psychologist, and a drug dependency counselor as well as repeated prescriptions for physical therapy. He has also offered me repeated prescriptions for anti-siezure medications, but doesnt think I need anything more than Ibuprofen for the pain.
Just went in for annual follow-up with Surgeon. I was informed that the "study" is officially ending effective immediately. I was told that STRYKER had ceased the FDA APPROVAL process. I was told that there are no problems with the study, but that STRYKER had just decided that there were enough "approved products" on the market and that this one would simply not be profitable enough in competition with the others that are approved. I am sorry, but it seems there is more to it than just that. I can not imagine that they would go as far as they had without a reasonable expectation of substantial profits.I asked the Surgeon and his assistant both if there are specific study results that they can share with me. Both said that the study had been very successful and that there was nothing to worry about.
An hour later, after exam, X-rays, etc. they said it appears that I have accelerated degeneration above and below the surgery area. The Surgeon reviewed X-rays and said he suspects that the disks have fused together and stopped moving as were designed. He said that this is the reason for the accelerated degeneration adjacent to the implant. He has me scheduled for more Physical Therapy, Another CAT Scan , MRI, and EMG tests in a few weeks. I am waiting for a response as to whether STRYKER is going to pay for these tests.
I hurt as bad now as I did before the surgery, but now I have to figure out what to do from here. Part of me wants it taken out, while at the same time I DREAD the idea of any more surgeries.
Any advice from others who are going through anything similar would be greatly appreciated. I am growing more and more regretful that I ever agreed to the procedure.
I look forward to hearing from any one who has had one removed or experienced any similar issues to mine.
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Hi, I am also a Cervicore subject. Philomena knows who I am. We have talked on several occasions. My surgery was done in 2006 and I had an immediate reaction after surgery. All my joints got extremely swollen and painful. I could hardly get up and down. That finally resided for the most part. still have trouble with it, but mostly have trouble with swollowing and right arm spasms and pain. Pins an needles all the time. Both hands jerk alot. I can not hold cups without dropping them. I have to use paper cups or anykind that I can bend to prevent dropping it. Now, The headaches and Neck pain is getting alot worse. Also, have a rash in my scalp, which is a sign of Metallosis. My fingers swell and get really painful. Its terrible. Stryker, should really recall these disc, but I do believe that we are all stuck with a life long torment. Anyway, theres tons more to tell, just wanted to join in here. Hopefullly, all of us can join forces and make a difference somehow.
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---I too am a Stryker implant victim. My implant was installed inDecember of 2006. My symptoms got worse and worse. I complained for nearly 3 years to the PI. He would tell me each time that I was OK and to continue PT.
I knew I was worse than before going in for an implant. I resorted to paying for another neurosurgeon that told me I was in perilous condition. I sent that dictation same day courier to my surgeon. Then and only then did he do another surgery and now I've the same symptoms but worse.
So far I cannot find aan attorney to take the case because of the statute of limitations. I sent letters to all the board members of Stryker and heard nothing back from them. I also lost my insurance through a divorce and I paid out of pocket for a myelogram all meds and some PT.
I am incapable of working and turning 58. I feel I was a victim of mal practice in an array of ways. Currently a law firm is reviewing my case and my file is large. We'll see.
How does one contact the FDA ?
Thanks ,Dave
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Dave, please contact me as soon as you get this. My ph number is a few posts above and all you need to do is to reply to this and it will go to my email addy which is the same as my screen name with at gmail dot com as the isp.
Looking forward to talking to u and I do have a complaint into the FDA and I will help you do the same. I have a lot of information and there is a group formed on facebook as well --
Looking forward to talking to u and I do have a complaint into the FDA and I will help you do the same. I have a lot of information and there is a group formed on facebook as well --
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Hi Guys, My husband as well had the cervicore implanted in 2008 in c4,c5 for a herniated disc. They claimed surgery went perfect. Neck pain remained and became worse. Shortly after his left fingers started tingling and arm began hurting. After several trips back to the doctor and more test they decided to fuse c6,c7 to replacement area. Pain still became worse in neck and left arm continues to regress. It got to the point where he was constantly dropping things and atrophy started setting in. After many Dr visits and them saying everything is fine on their end, they sent us to a hand surgeon (a dr associated with their office) who in turn had a nerve test done. She claimed ha had cubital tunnel syndrome and sliced open his entire arm to move the ulnar nerve. His arm continues to throb and finger tips would tingle and get ice cold as well as the neck issues continuing to get worse. He describes the neck pain as a throbbing pressure which goes to his upper back between spine and shoulder area and feels like stabbing pain. Of course the doctors blame the arms on the damaged nerves in his back now. As of a few months back now his right arm is doing the same as the left. He cant even button his own pants hardly from atrophy in both hands, which is visible in both hands.You can literally see the muscle is gone between his thumb and index finger. We had another nerve test done and As of the last visit with the neurosurgeon and the nurse consultant with stryker they claimed it was the T1 and he was now high risk and theres nothing they can do. Lovely, isnt it? My friend who is a PT set us up with a Medicine Rehap Doctor research team that works out of Wayne State to see if rehab would help. He looked over the recent MRI and showed us where the C3C4 is putting compression on the spinal cord and suggested we see a neurosurgeon quickly. And suggested we get several opinions which stinks because other doctors know little if any about this disc. He did explain the urgency of surgery because the spinal cord can only take compression for so long in that area for a possibility for his hand function to return. Any helpful stories or resolved issues please share. We looked onto a lawyer once about the arm surgery which wasnt needed. They said it was to hard to prove. That was prior to finding this. I did a letter from Stryker informing us that our services in the research were no longer needed as they were no longer seeking FDA approval due to there already being enough products on the market. That was in February.How do we log a complaint with the FDA?
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Tara, this is Philomena.55. I would like to speak with you as soon as possible. Are you in Detroit Metro area? I am in Southfield, MI. We NEED to talk as soon as possible as I may have some important information that may help us.
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