The reported event could not be confirmed, since the device was not returned for evaluation and only an x-ray was shared by the customer.With the available medical information and the x-ray provided, a medical opinion was sought from the medical expert, but no conclusive statement or opinion could be made due to insufficient information.More detailed information about the complaint event as well as the affected device, pre-operative x-ray, post-operative x-ray and patient¿s medical records must be available in order to determine the root cause of the complaint event.The probable root cause of the complaint event could be due to poor positioning of the lag screw and the patient factor.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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