FDA Adverse Event
Injury
Summary report: N
SYNTHES
MDR report key: 1020764
·
Received March 27, 2008
Report
- Report Number
- 1020764
- Event Type
- Injury
- Date Received
- March 27, 2008
- Date of Event
- February 29, 2008
- Report Date
- March 5, 2008
- Manufacturer
- SYNTHES - WEST CHESTER
- Product Code
- KWQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AR, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
LONG STANDING HISTORY OF BACK PAIN REFRACTORY CONSERVATIVE CARE AND HAD UNDERGONE MULTIPLE PROCEDURES. FRACTURE OF HARDWARE, AND WHAT APPEARED TO BE IMPENDING PSEUDOARTHROSIS POSTERIOR FUSION ATTEMPTED. UNFORTUNATELY, FAILED TO HEAL. ADMISSION FOR REVISION PROCEDURE TO INCLUDE REMOVAL OF BROKEN HARDWARE, REMOVAL OF PSEUDOARTHROSIS, EXPLORATION OF FUSION MASS AND REVISION FUSION WITH INSTRUMENTATION. IT WAS FOUND THAT THE PLATE SCREWS HAD ALL BEEN LOCKED INTO PLACE. APPROPRIATELY WITH ONLY ONE SCREW BACKING OUT (BOTTOM LEFT-HANDSIDE). THOSE SUPERIORLY HAD BROKEN, THE ONE INFERIORLY HAD HELD, AND ONE INFERIORLY HAD BACKED OUT SOMEWHAT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTHES | HARDWARE | KWQ | SYNTHES - WEST CHESTER | PLATE 5088140, SCREW 5033632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization |