No device malfunction alleged so no device was returned for evaluation.No radiographs, photographs or test reports have been provided to confirm the alleged event.Labeling review: ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." ".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.".
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On (b)(6) 2019, a patient underwent a spinal procedure from t11 to l1 levels with no reported issues.As per reporter on (b)(6) 2019 patient underwent a revision procedure due to a patient fall.The l1 left screw was replaced and the l1 right screw was removed, the existing construct was also extended down to the l3 level.
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