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 percutaneous pedicle screw placement at l2-l3, crosslink placement was performed at s1, screw insertion was performed at s2ai and rods were inserted on both sides.On an unknown date, post-op, the screw backed-out at right side of l2.Along with the alleged screw, the screw at right side of l3 backed-out; and left side of the crosslink at s1-s2ai deviated (backed-out) from sacrum.Hence, a revision surgery, was performed, in which, the backed-out crosslink was explanted and was replaced with a new one.The backed-out screws were removed; and were replaced with screws of bigger size, with change in insertion angle.Rod placement was performed again.Additional crosslink placement was performed between l2-l3.The procedure was then completed.There was a delay of more than 60 minutes in overall procedure.
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