Quote:
Originally Posted by Dubious
Not trying to muddy the water but from the "web"....
Adverse Events Reported to FDA
A handful of adverse event reports have been submitted to the FDA on behalf of patients who underwent surgery using the ROI-C cervical cage. One physician claimed that immediately following surgery, the patient was not able to move his extremities. An MRI revealed that hardware of the device was impinging upon the patient's spinal cord. The patient underwent surgery to remove the device, but still reportedly suffers from no movement in the arms and minimal movement in the lower extremities. The surgeon claims that the patient's injuries stem from a "catastrophic failure" of the cage.
A similar adverse event report noted that immediately following surgery, the patient experienced adverse neurological symptoms, specifically a lack of movement in the extremities. The report claims that the patient needed surgery to remove the device, but that he still suffered limited movement of the legs and no movement of the arms. According to an investigation into the incident, the surgeon followed proper technique for implanting the device, but reported difficulty impacting one of its anchor plates. It has been suggested that the anchor portion of these devices may break, causing serious side effects and, in some cases, necessitating a second surgery to remove the device.
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So scared! When I woke up from surgery, I begged them to put me back to sleep because the pain at the base of my neck was unbearable. My left arm was dead weight but it didn't hurt and my left hand was 'drawn'. I could move it but it was difficult. My dr said not to worry. The severe pain in my neck lasted for weeks, no pain med touched it. When I moved my arms, to reach for something, I would get sharp knife like stabs across my shoulder. Had a MRI 3 weeks post op, dr said everything was ok....my left arm was still very heavy and glued to my side. Then it was like the feeling started coming back to my arm, but it was very painful. It now hurts to move it out away from my body or up. 8 weeks out, I was finally given neurontin, which saved my life. I just got a cortisone shot in my shoulder 2 days ago and I can move it a little better. My neck still hurts, but nothing like the first 8 weeks, I'm now 15 weeks post op. this whole time my dr keeps saying I have o give it time. X-rays show the cage looks good but no fusion yet. I cant lift anything without it pulling on my neck. my head still feels to heavy for my neck. ihate that I didn't research about the device he used, but I trusted him. I've read several reports about the roi-c since my surgery that have not been good. Its suppsed to give patients a better rom. Just praying everything works out good.