FDA Adverse Event
Other
Summary report: N
ZIMMER MINI 2.0 14MM SCREW
MDR report key: 1881894
·
Received October 19, 2010
Report
- Report Number
- MW5017857
- Event Type
- Other
- Date Received
- October 19, 2010
- Date of Event
- September 24, 2010
- Report Date
- October 19, 2010
- Manufacturer
- ZIMMER
- Product Code
- HWC
- Report Source
- Voluntary report
- Reporter Location
- AK, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
ORIF RT. INDEX METACARPAL. A ZIMMER 2.0 14MM SCREW WAS PLACED AT THE PROXIMAL END OF THE FRACTURE SITE FOR STABILITY. AN X-RAY WAS MADE TO VERIFY PLACEMENT AND THE SCREW WAS FOUND TO BE BENT AND NOT MAINTAINING THE STABILITY OF THE FRACTURE. THE BENT SCREW WAS REMOVED AND REPLACED WITH ANOTHER ZIMMER 2.0 14MM SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER MINI 2.0 14MM SCREW | BONE SCREW | HWC | ZIMMER | 2320-15 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Other |