IMPLANT HOLDER 10 MM

Additional Manufacturer Narrative

ADDITIONAL NARRATIVE: THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THIS DEVICE IS NOT SIMILAR TO ANY DEVICE SOLD/AVAILABLE IN THE US. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPERATION TO IMPLANT IN-SPACE IMPLANTS, TWO SCREWDRIVERS, AN IMPLANT HOLDER AND TWO TORQUE LIMITERS DID NOT FUNCTION PROPERLY. NO PATIENT ADVERSE CONSEQUENCES HAVE BEEN REPORTED. THE PROCEDURE WAS PROLONGED FOR ABOUT TWENTY-FIVE MINUTES. THIS IS REPORT 3 OF 5 FOR (B)(6).

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. REVIEW OF THE DEVICE`S TEST PROTOCOL SHOWED THAT THERE WERE NONCONFORMANCIES: IN 3 OF 20 IMPLANT HOLDERS, THE LOCKING SCREW COULD ONLY BE INSERTED IN THE IMPLANT HOLDER WITH LIGHT EXERTION OF FORCE. ALSO THERE WERE SOME VISUAL DEVIATIONS LIKE SLIGHTLY FADED MARKINGS FOUND. HOWEVER, ALL PARTS WERE RELEASED AFTER REWORK. NEXT TO THAT NEITHER THE NEEDED SLIGHT FORCE OF LOCKING SCREW INSERTION NOR THE VISUAL DEVIATIONS WOULD BE COMPLAINT RELATED AS THE COMPLAINT IS REGARDING MOVING OF THE IMPLANT WINGS AND REGARDING ATTACHING THE IMPLANT OR THE LOCKING SCREW. 4 OF 20 IMPLANT HOLDERS HAD SUPERFICIAL DAMAGE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.