FDA Adverse Event
Injury
Summary report: N
ONE-THIRD TUBULAR PLATE WITH COLLAR
MDR report key: 1895292
·
Received November 2, 2010
Report
- Report Number
- 1822565-2010-01051
- Event Type
- Injury
- Date Received
- November 2, 2010
- Date of Event
- August 18, 2010
- Report Date
- October 5, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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 PT WAS REVISED DUE TO BREAKAGE OF THE PLATE. X-RAYS CONFIRMED PRIOR TO SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE-THIRD TUBULAR PLATE WITH COLLAR | TRAUMA PROSTHESIS | KWY | ZIMMER, INC. | 60812281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |