The reported event was confirmed by review of the radiographic image provided.No product was returned to nuvasive for evaluation as the device was repositioned and remains in-situ.Operative notes were not provided for review of usage/technique.Based on the information provided by the complainant, the root cause is considered to be an inadvertent use error and the result of screw malplacement during the implantation procedure.Labeling review: ".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: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity." ".Warnings, cautions and precautions: the safety and effectiveness of these devices for any other conditions are unknown.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." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
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