FDA Adverse Event
Malfunction
Summary report: N
MINI MAGNA-FX CANNULATED SCREW
MDR report key: 2822816
·
Received November 2, 2012
Report
- Report Number
- 1822565-2012-02254
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- October 4, 2012
- Report Date
- October 4, 2012
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- 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 SCREW THREAD IS BENT AND CAN NOT BE USED WITH THE PIN. A DIFFERENT SCREW WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINI MAGNA-FX CANNULATED SCREW | HWC | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |