IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH A HERNIATED DISC AT C4-C5 AND UNDERWENT A TOTAL DISC REPLACEMENT WITH PRODISC-C. DURING THE PROCEDURE, THE SMALL PIECE IN THE TRIAL IMPLANT STOP FELL OFF INTO THE PATIENT. THE LITTLE PIECE CAUSED THE INSTRUMENT TO ADVANCE TOO FAR. THE SURGEON NOTICED AND PULLED THE TRIAL OUT AND RETRIEVED THE LITTLE PIECE THAT FELL OFF. THERE WAS NO REPORTED ADVERSE EVENT OR DELAY. THE PATIENT IS REPORTEDLY DOING FINE. ON AN UNKNOWN DATE IN 2008, THE PATIENT ALSO HAD A PREVIOUS PRODISC-C SURGERY BY THE SAME SURGEON WHICH IS STILL IMPLANTED. THE PATIENT EXPERIENCED A HERNIATED DISK AT AN ADJACENT LEVEL C5-C6 AND UNDERWENT A TOTAL DISC REPLACEMENT WITH PRODISC-C. THERE WAS NO ALLEGATION OF DEFICIENCY AGAINST THE IMPLANT NOTED. THIS IS REPORT 1 OF 2 FOR (B)(4).
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Patient 1
(B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIALS WHICH WERE DELIVERED ARE CORRESPONDING TO THE SPECIFICATIONS. THERE WERE NO NCRS GENERATED DURING PRODUCTION. 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: A MANUFACTURING EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT THE 03.820.046 IS ONE TRIAL (17MM W X 14MM D X 6MM H) IN THE FAMILY OF PRO-DISC C TRIALS. THE TRIALS CONNECT TO THE 03.820.000 TRIAL HANDLE WHICH ALLOW THE SURGEON TO DETERMINE THE PROPER HEIGHT, WIDTH, AND DEPTH OF THE PRO-DISC C IMPLANT. THE TRIALING STEPS OF THE PRO-DISC C PROCEDURE CAN BE FOUND IN THE TECHNIQUE GUIDE J7501-E. THE TRIAL HAS A THREADED DESIGN FEATURE WHICH ALLOWS THE SURGEON TO ADVANCE THE TRIAL BODY DEEPER INTO THE DISC SPACE TO ENSURE PROPER POSTERIOR PLACEMENT OF THE IMPLANT. THE INITIAL STEP PRIOR TO TRIALING IS TO ROTATE THE TRIAL HANDLE/TRIAL CLOCKWISE TO GET THE TRIAL TO THE MOST ANTERIOR PLACEMENT. EACH COUNTERCLOCKWISE ROTATION ADVANCES THE TRIAL 0.5MM POSTERIOR. PER THE COMPLAINT DESCRIPTION, THE DEVICE LOST THE CLIP WHICH WAS RETRIEVED BY THE SURGEON. THE CLIP IS LASER WELDED PER 03_820_045 REV H WHICH IS SUFFICIENT FOR THE DESIGN FEATURE AS THE CLIP INTERFACE SHOULDN'T EXPERIENCE LOADING WHICH WOULD PUSH OUT THE CLIP AND CAUSE THE LASER WELD TO FAIL. THE LIBERATED CLIP WAS NOT RETURNED. THE CHU ENGINEER REVIEWED ENGINEERING DRAWINGS AND THE MATERIALS AND SPECIFICATIONS ARE ADEQUATE FOR THE DEVICE'S INTENDED USE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
N
Patient 1
ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CONSIDERING THE CLIP WAS SECURED WITH 4 LASER POINTS, TOO MUCH FORCE CAUSING IT TO FELL OFF. (B)(4). A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE 03.820.046 IS ONE TRIAL (17MM W X 14MM D X 6MM H) IN THE FAMILY OF PRO-DISC C TRIALS. THE TRIALS CONNECT TO THE 03.820.000 TRIAL HANDLE WHICH ALLOW THE SURGEON TO DETERMINE THE PROPER HEIGHT, WIDTH, AND DEPTH OF THE PRO-DISC C IMPLANT. THE TRIALING STEPS OF THE PRO-DISC C PROCEDURE CAN BE FOUND IN THE TECHNIQUE GUIDE J7501-E. THE TRIAL HAS A THREADED DESIGN FEATURE WHICH ALLOWS THE SURGEON TO ADVANCE THE TRIAL BODY DEEPER INTO THE DISC SPACE TO ENSURE PROPER POSTERIOR PLACEMENT OF THE IMPLANT. THE INITIAL STEP PRIOR TO TRIALING IS TO ROTATE THE TRIAL HANDLE/TRIAL CLOCKWISE TO GET THE TRIAL TO THE MOST ANTERIOR PLACEMENT. EACH COUNTERCLOCKWISE ROTATION ADVANCES THE TRIAL 0.5MM POSTERIOR. PER THE COMPLAINT DESCRIPTION, THE DEVICE LOST THE CLIP WHICH WAS RETRIEVED BY THE SURGEON. THE CLIP IS LASER WELDED PER 03_820_045 REV H WHICH IS SUFFICIENT FOR THE DESIGN FEATURE AS THE CLIP INTERFACE SHOULDN'T EXPERIENCE LOADING WHICH WOULD PUSH OUT THE CLIP AND CAUSE THE LASER WELD TO FAIL. THE LIBERATED CLIP WAS NOT RETURNED. THE CHU ENGINEER REVIEWED ENGINEERING DRAWINGS AND THE MATERIALS AND SPECIFICATIONS ARE ADEQUATE FOR THE DEVICE'S INTENDED USE. 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.