No product was returned for evaluation and no radiographs could be provided confirming the event.Review of the provided information suggests the root cause of the issue is user error during installation as it was admitted that the device was misassembled during installation.No additional investigation can be completed."potential adverse events and complications.As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include.Potential risks identified with the use of this system, which may require additional surgery, include:.Bending, fracture or loosening of implant component(s).Loss of fixation." ".Warnings, cautions and precautions.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.".
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On (b)(6) 2021 a patient underwent a posterior fixation procedure.In (b)(6) on a unknown date during a routine post op follow up a radiograph revealed that the that the rod was installed in reverse against the curvature, causing the screw loosening.On (b)(6)2021 a revision occurred where the loose screw was replaced with a new screw, and the fixation level was extended one vertebra to the cranial side.Reportedly the operation was successfully completed and the patient has been recovering.
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