FDA Adverse Event
Malfunction
Summary report: N
BLOCKER
MDR report key: 2903694
·
Received January 4, 2013
Report
- Report Number
- 3003853072-2012-00026
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Report Date
- December 5, 2012
- Manufacturer
- ZIMMER SPINE
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BLOCKER LOOSENED POST-OPERATIVELY. NO FURTHER INFO IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5185 | BLOCKER | BLOCKER | LXH | ZIMMER SPINE | 046W0AN00002 | E60128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |