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.(b)(4).Was cleared in the united states.If information is provided in the future, a supplemental report will be issued.
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Information was received from a health care professional via manufacturer representative regarding screws used in posterior fusion.Levels implanted: t1-11.Pre-operative diagnosis for this procedure ais type2.It was reported that navigation was used from caudal side, the screw was inserted, screws were inserted from the caudal side alternately left and right.It was felt to be deviated a little, so it was checked with ct when coming to th7.It was noted that the screws of the 7th, 8th, and 9th thoracic vertebrae on the left side had deviated.The screw was inserted with navi, but it did not pass through the pedicle and was stuck in the spinal canal.After that, the screw was inserted without using navi with no problem.However, the number of nerve monitoring dropped significantly.After the operation leg moved, but it is unknown at this time whether there were sequelae.The screws were inserted again, and the operation was proceeded and completed.Implant products are being implanted.There was no patient health damage problem.There was a delay of less than 60 min in overall procedure time.
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