ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: ALL FOUR WINGS ARE STILL UN-DEPLOYED AND PARTIALLY BROKEN. IN ADDITION CIRCULAR MARKS ARE CLEARLY VISIBLE ON THE CONNECTING END OF THE IMPLANT. BASED ON THIS FINDING WE HAVE TO ASSUME THAT THE IMPLANT WAS NOT ATTACHED CORRECTLY ONTO THE IMPLANT HOLDER (THE SLOTS OF THE IMPLANT DID NOT MATCH WITH THE TAPPETS OF THE IMPLANT HOLDER), RESULTING IN A WRONG ORIENTATION OF THE IMPLANT AND FINALLY PREVENTING THE DEPLOYMENT OF THE WINGS AS THE WINGS WERE COVERED BY THE WALL OF THE SLEEVE. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THIS LOT OF (B)(4) PIECES WAS MANUFACTURED IN SEPTEMBER 2010, ALL PARTS ARE SOLD AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE AND LOT NUMBER. NO PRODUCT FAULT COULD BE DETECTED. NO PRODUCT FAULT COULD BE DETECTED. (B)(4). 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.
N
Patient 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
D
Patient 1
IT WAS REPORTED THAT WHILE PREPARING THE INSTRUMENTS USED IN THIS CASE FOR ANOTHER CASE, IT WAS NOTICED THAT THE INSTRUMENTS WERE BROKEN, DAMAGED OR DEFECTIVE. IT IS THOUGHT THE BROKEN INSTRUMENTS ARE RELATED TO THE BROKEN IMPLANT FROM THE PROCEDURE.
N
Patient 1
ADDITIONAL NARRATIVE: DEVICE WAS NOT IMPLANTED/EXPLANTED. (B)(4). 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.
D
Patient 1
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING THE SURGERY AT THE TIME OF THE INTRODUCTION OF THE IMPLANT, THE DEVICE WINGS ARE NOT FULLY OPEN AND BREAK. THE IMPLANT WAS REMOVED FROM THE PATIENT. THE SURGERY WAS PROLONGED ABOUT 20 MINUTES DUE TO THE REPORTED DEVICE ISSUE. THIS REPORT IS 1 OF 1 FOR (B)(4).
N
Patient 1
PATIENT IDENTIFIER AND AGE WERE NOT PROVIDED BY REPORTER. 510(K) DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.