The device remains in-situ.No radiographs were provided to confirm the event.It is unknown if the patient complied with post-operative instructions or was subjected to an impact that may have contributed to the event.The surgery reportedly involved the use of another manufacturer's product; this may also have contributed to the event.No further investigation can be completed at this time.Root cause has not been determined and no conclusion can be drawn.Review of labeling notes: "warning and cautions and precautions potential risks identified with the use of this device system, which may require additional surgery include:.Bending or loosening of implant, loss of fixation." "care should be taken to insure that all components are ideally fixated prior to closure." "confirm heights of screws match with patient's lordosis when securing lock screws.Failure to verify screw height following insertion may result in inadequate rod normalization.Final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.Ensure there is enough rod overhang when final tightening, and do not lock down on the conical portion of the rod.Failure to do so may lead to improper lock down of the construct.It may be necessary for the surgeon to add length to the rod, depending upon patient anatomy and desired lordosis." "compatibility: do not use the precept spinal system with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." device was left in-situ.
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