| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LUMBAR WEDGED I/F CAGE | SPINAL PEDICLE SCREW, FIXATION, APPLIANCE SYSTEM | DEPUY SYNTHES SPINE | MCV | 173121207 | 5085964 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-10-13 | 0 |
Patient 1
INTERNATIONAL AFFILIATE REPORTS THE LUMBER WEDGED I/F CAGE CRACKED WHEN IT WAS INSERTED INTO THE PATIENT. THE SURGEON REMOVED THE CAGE AND INSERTED OTHER ONE. AT THIS TIME, IT IS NOT KNOWN IF THERE WAS A SIGNIFICANT DELAY TO THE PROCEDURE. HOWEVER, NONE WAS REPORTED.
Patient 1
A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Patient 1
VISUAL INSPECTION REVEALED THAT THE RETURNED LUMBAR WEDGED I/F CAGE HAD FRACTURED (BUT STILL INTACT) ON EITHER SIDE OF THE TAPPED INSERTER HOLE. THE THREADS DO NOT APPEAR TO HAVE BEEN STRIPPED. THE DAMAGE IS CONSISTENT WITH A CAGE THAT MAY NOT HAVE BEEN FULLY TIGHTENED ON THE INSERTER WHICH WAS SUBJECTED TO HIGHER THAN ANTICIPATED SIDE LOADING. A REVIEW OF THE DHR IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. TRENDING WAS COMPLETED AND NO IMMEDIATE PRODUCT ACTION IS REQUIRED. AN INTERNAL DATA REVIEW HAS BEEN OPENED TO REVIEW DESIGN CONTROL DOCUMENTATION AND SIMILAR FAILURES WILL BE MONITORED AS A PART OF POST MARKET SURVEILLANCE ACTIVITIES. THE ROOT CAUSE CANNOT BE POSITIVELY IDENTIFIED BASED ON THE PROVIDE INFORMATION OR RETURNED SAMPLE. HOWEVER, THE OBSERVED DAMAGE IS CONSISTENT WITH A CAGE THAT MAY NOT HAVE BEEN FULLY TIGHTENED ON THE INSERTER WHICH WAS SUBJECTED TO HIGHER THAN ANTICIPATED SIDE LOADING RESULTING IN A CONCENTRATED LOADING AROUND THE TAPPED HOLE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.