This report is being resubmitted for an incident that occurred earlier.The device was returned for evaluation.Initial observation shows a fracture at the distal tip just past the first thread.Additional information provided that during implantation, the spacer went laterally off trajectory which prompted the surgeon to remove the cage for repositioning.The surgeon was reported to be rocking the cage laterally and tapping on the inserter to try to loosen the cage in the space.While pulling on the attached inserter the inserter detached revealing the threaded rod had sheared off.It is possible the device had fatigued under regular use resulting in the failure.However, an exact cause of the reported issue could not be determined.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.
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