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 adolescent idiopathic scoliosis.The first surgery was performed on (b)(6) 2020.The patient was still in pain, so the doctor planned a re-operation.The screw that caused the patient's pain cannot be identified.Re-operation was performed on (b)(6) 2020.Reason for revision is rib pain that is thought to be due to screw nerve interference after ais correction and fusion.There is delay of less than 60min in overall procedure time.The implanted screws were not removed, but were corrected.Doctor used the ari extender when the reoperation was corrected.The ari extender was hard to come off the screw.It was the five screws that made it difficult for the extender to come off.Since the screw that caused the pain could not be identified, it was judged that there was a possibility of pain in the five screws that the extender had difficulty in removing.No health damage in the patient was reported.
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