FDA Adverse Event
Injury
Summary report: N
SEQUOIA AND PATHFINDER NXT CLOSURE TOP
MDR report key: 4360586
·
Received December 18, 2014
Report
- Report Number
- 2184052-2014-00198
- Event Type
- Injury
- Date Received
- December 18, 2014
- Date of Event
- November 20, 2014
- Report Date
- November 27, 2014
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- NKB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
SAME CASE AS: 2184052-2014-00202. IT WAS REPORTED THAT TWO SCREW NUTS CAME LOOSE POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 831478 | SEQUOIA AND PATHFINDER NXT CLOSURE TOP | SEQUOIA AND PATHFINDER NXT CLOSURE TOP | NKB | ZIMMER SPINE, INC. | 3301-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |