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.Reference reports 3004485144-2016-00388 - 3004485144-2016-00391, 3004485144-2016-00393, and 3004485144-2016-00394.
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It was reported that during a revision surgery, both rods were found broken in the lumbar region, where a pedicle subtraction osteotomy had been previously performed, and the closure tops had loosened.There were also closure tops which loosened in the cervical spine.Only t7-pelvis was revised.The patient was revised using competitor products.This is report one of six for this event.
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