No films, cts, or radiographs confirming the event were received.Lot numbers could not be verified as the devices were not returned.No further product evaluation could be completed at this time.Patient activity at the time or prior to the event is unknown.The degree of spinal instability is unknown.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact of some sort.Multiple attempts to gain further information made with no response.Review of labeling notes: warning cautions and precautions, "loosening, bending, dislocation, and/or breakage of the components, possibly requiring further surgery." the root cause of this reported event has not been determined.
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