| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TRIAL SPACER HANDLE | HANDLE, SCALPEL | SYNTHES HAGENDORF | GDZ | 397.089 | 8135125 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-02 | 0 |
Patient 1
IT WAS REPORTED THAT DURING ROUTINE INSPECTION OF FIELD EQUIPMENT, THE TIP OF A TRIAL SPACER HANDLE WAS FOUND TO BE BROKEN OFF IN AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) TRAIL SPACER. IT WAS ALSO DISCOVERED THAT THE TIP OF ANOTHER TRIAL SPACER HANDLE WAS BROKEN OFF. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 2 OF 2 FOR (B)(4).
Patient 1
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JANUARY 21, 2013 NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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.
Patient 1
A PRODUCT INVESTIGATION EVALUATION WAS PERFORMED: THE RETURNED TRIAL SPACER HANDLE WITH THE BROKEN TIP (LOT 813125) WAS EVALUATED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE DISTAL TIP OF THE INNER SHAFT WAS BROKEN OFF AND RETAINED IN THE RETURNED TRIAL SPACER. THE FAILURE MODE IS CONSISTENT WITH THE APPLICATION OF EXCESSIVE FORCE AND/OR OFF-AXIS LOADING. ADDITIONALLY A SECOND TRIAL HANDLE SPACER WAS RETURNED (LOT 8186052); THIS DEVICE WAS RECEIVED UNDER THE COMPLAINT CONDITION BROKEN TIP, HOWEVER THE COMPLAINT CONDITION WAS UNABLE TO BE CONFIRMED AS THE TIP ON THE RETURNED INSTRUMENT WAS INTACT. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENTS WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. 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.