Patients who underwent spinal fusion surgery using the ROI-C cervical cage manufactured by LDR and suffered serious post-operative complications may have legal recourse. It has been alleged that implantation of the device has been linked to serious nerve and spinal cord injuries and the recurrence of problems experienced prior to surgery. Some patients have also reported that they needed to undergo a second surgery – sometimes immediately – to remove the device.
If you or a loved one suffered these problems following surgery using the ROI-C cervical cage, you may be able to take legal action against the manufacturer for your losses. To find out if you can seek compensation for medical bills and other damages stemming from your injuries, contact us today for a free case evaluation. There is no cost or obligation to have your side effects reviewed.
A number of adverse event reports have been submitted to the FDA on behalf of patients who underwent surgery with the ROI-C cervical cage. In two reports, both patients suffered a lack of movement in the extremities immediately after the operation and were taken back to surgery to remove the device. Even after the second surgery, both patients suffered minimal movement in the legs and no movement of the arms. One physician related his patient’s complications to the "catastrophic failure of the cage." An investigation into the other report revealed that the surgeon followed proper technique, but struggled when impacting one of the anchoring plates. Allegations have surfaced that the anchor portion of the cervical cage can break and cause spinal and nerve injuries.
The ROI-C cervical cage was streamlined to the market using the 510(k) process. Instead of submitting the results of efficacy and safety testing for approval, the manufacturer simply had to show that the product was "substantially equivalent" to an already-approved device. This process has received considerable criticism, with a recent Institute of Medicine report calling the process "flawed." The report also said that the process needs not to be reworked, but rather replaced. A number of highly controversial devices have achieved market clearance using this process.
If you or a loved one suffered from spinal or nerve injuries follow surgery with the ROI-C cervical cage, you may be able to file a lawsuit against the manufacturer. A lawsuit can help patients seek compensation for physical pain, medical expenses related to their side effects, and other damages. To learn more about your potential legal rights, fill out our free, no obligation case review form with the details of your complications.