Dhr - review of manufacturing records for spip-520-1-ww cmr 163711t showed no evidence of a nonconformance that may have caused or contributed to the reported event.Failure analysis - the device in question has not been returned to date.Images of the explanted spip were provided showing the device in two pieces, separated at the hinge, confirming the reported event.Root cause - based on the information received to date, the root cause is undetermined.The event may be due to trauma or an improperly seated implant leading to additional stress on the hinge may have caused or contributed to the event.
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