FDA Adverse Event
Malfunction
Summary report: N
ZIMMER NATURAL NAIL SYSTEM 3.0 MM THREADED
MDR report key: 2151308
·
Received June 21, 2011
Report
- Report Number
- 1822565-2011-01445
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 21, 2011
- Report Date
- May 26, 2011
- Manufacturer
- ZIMMER INC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE THREADED PIN BROKE IN THE PT'S BONE AND REMAINS IN THERE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER NATURAL NAIL SYSTEM 3.0 MM THREADED | LXH | ZIMMER INC | 07891333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |