FDA Adverse Event
Injury
Summary report: N
ROD
MDR report key: 2423177
·
Received January 13, 2012
Report
- Report Number
- 2520274-2012-00055
- Event Type
- Injury
- Date Received
- January 13, 2012
- Report Date
- December 19, 2011
- Manufacturer
- SYNTHES (USA)
- Product Code
- NQP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.
Description of Event or Problem · 1
PATIENT UNDERWENT AN L4-S1 PLIF PROCEDURE ON AN UNKNOWN DATE. PATIENT EXPERIENCED ADJACENT LEVEL DISC DISEASE AT L3-L4 AND THE ENTIRE CONSTRUCT WAS REMOVED FROM L4-S1. SURGEON REMOVED SCREWS, LOCKING CAPS AND RODS ON (B)(6) 2011. PATIENT REVISED FROM L3-S1 WITH SCREWS, LOCKING CAPS AND RODS. SURGEON WAS UNABLE TO IMPLANT THE RIGHT L4 SCREW AND COMPLETED REVISION PROCEDURE WITHOUT SCREW. HARDWARE NOT AVAILABLE FOR RETURN. THIS IS THE 14TH OF 14 REPORTS SUBMITTED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROD | NQP | SYNTHES (USA) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | RODS| SCREWS| LOCKING CAPS |