The reported event that lag screw, ti gamma3® ø10.5x85mm was alleged of ' implant - dislocated' could be confirmed (consulting the x-ray).Based on investigation, the root cause was attributed to be patient related.The failure was caused after patient fell and lag screw went through the femoral head.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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