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 the patient underwent transforaminal lumbar interbody fusion (tlif) surgery at l4/l5 due to lumbar spinal canal stenosis, radiculopathy.Post-op, the screw was inserted into right of l5 using a navigation but the inserted screw was turned out and deviated after the operation.Hence on (b)(6) 2019, revision surgery was performed due to the screw deviated.Patient symptoms or complications is unknown at this time.
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