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Member
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Join Date: Jan 2009
Location: Paradise
Posts: 855
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Member
Join Date: Jan 2009
Location: Paradise
Posts: 855
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Quote:
Originally Posted by Cocoa14
He used the ROI-C which does not require screws. I'm so scared! He just keeps saying give it time.
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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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