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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Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of radiculopathy.It was a revision surgery.Initial surgery is performed on (b)(6) 2020.In the initial surgery, the position was changed after performing anterior spinal fusion with olif at l4 / 5.Posterior spinal fixation was performed on one intervertebral disc at l4-5.After initial surgery, the left l5 screw deviated laterally upward, and the l4 nerve root was compressed and there was radiculopathy, so re-operation was performed to correct the screw orbit on (b)(6) 2020.As per doctor opinion ,the reported event was not related to the use of medtronic products.The deviation of screw was a human error according to physician's opinion.The screw of l5 was replaced and the rod was connected again.There was no malfunction occurred with product itself.
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