FDA Adverse Event
Injury
Summary report: N
SEQUOIA AND PATHFINDER NXT CLOSURE TOP
MDR report key: 4092325
·
Received August 20, 2014
Report
- Report Number
- 2184052-2014-00172
- Event Type
- Injury
- Date Received
- August 20, 2014
- Date of Event
- August 6, 2014
- Report Date
- August 12, 2014
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- NKB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE CLOSURE TOPS LOOSENED POST-OPERATIVELY. THE ORIGINAL SURGERY TREATED L3-S1 WITH SEQUOIA INSTRUMENTATION AND TM-300. THE CLOSURE TOPS ON THE RIGHT L3-L5 WERE FOUND TO BE COMPLETELY OUT OF THE SCREW. REVISION SURGERY WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 503905 | SEQUOIA AND PATHFINDER NXT CLOSURE TOP | SEQUOIA AND PATHFINDER NXT CLOSURE TOP | NKB | ZIMMER SPINE, INC. | 3301-1 | 62RR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |