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 3004485144-2016-00007 thru 3004485144-2016-00010, 3012447612-2017-00154 thru 3012447612-2017-00157, and voluntary report mw5068372.
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It was reported that a revision surgery was performed to address pseudoarthrosis at levels t12-l1 and l2-l3.Information from voluntary medwatch mw5068372 states that the revision also addressed cap screws which were not tight, followed by screws which were loose, followed by broken rod, and an infection.This is report six of eight for this event.
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