The lot number was reported to be either n288197 or n295595.No product was returned as no product fault was alleged and the involved device remains in-situ.No radiographs could be provide showing the initial or revised construct confirming the complaint.No additional information could be obtained.The root cause is considered to be an inadvertent use error and the result of screw malplacement during the index 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." "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.".
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