Without a product return, no product evaluation can be conducted.Review of traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.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.Device not returned.
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Roi-a : damaged cage and plates did not deploy properly.As reported during a roi-a surgery, implant holder stripped peek cage, the implant did not stay on instrument, therefore the plates did not deploy properly.Another implant was opened to complete surgery.Instrumentation set was inspected in field return and found compliant.No other information provided.
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