Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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It was reported that patient underwent an unknown surgery at l4-5.Post-op, patient reported hip and thigh pain.Pain started 5 months another surgery (hip replacement).Reportedly, patient underwent x-ray with imaging which showed that the device was fine and in good position, but may have bone growing around it.Surgeon has suggested removal and fusion, but has not decided to do that at this time.
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