D10: 824m6550, lot unknown, qty 3, vital mis screw; 07.02010.001, lot unknown, qty 3, closure top; 815m1050, lot unknown, qty 2, percutaneous rod; 14-533173, lot unknown, qty 1 zyston curved spacer.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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It was reported that at the patient's initial post-op appointment, the x-rays revealed the closure top on the left l4 screw had migrated out of its mating screw.The surgeon performed a revision surgery specifically to revise the left side of l4 tlif, extracting the migrated vital mis set screw from left l4.During the revision, the closure top was removed and replaced and the screw was removed and replaced with a larger diameter screw.This is report one of two for this event.
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