The implant was used for treatment, not diagnosis.It remains in situ.Radiograph images were not provided to confirm the event.The date of the postoperative visit is unknown.The identifying lot number was not provided; therefore, a review of the device history records could not be conducted.Based on the information provided, a root cause could not be determined.If additional information is provided, a supplemental report will be submitted.Labeling review: "intraoperative management: final tightening of set screws: all set screws must be tightened using the appropriate instruments (e.G., torque handle, final driver, and counter torque) as indicated in the surgical technique guide.Warnings/cautions/precautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Do not final tighten under compression or distraction as the rod may not be normalized to the tulips, resulting in rod slippage.Failure to tighten set screws using the recommended instrument(s) could compromise the mechanical stability of the construct.Possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.".
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