FDA Adverse Event
Injury
Summary report: N
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM LOCKING SCREW
MDR report key: 722596
·
Received June 2, 2006
Report
- Report Number
- 1822565-2006-00135
- Event Type
- Injury
- Date Received
- June 2, 2006
- Date of Event
- April 22, 2006
- Report Date
- May 2, 2006
- Manufacturer
- ZIMMER, INC.
- Product Code
- HWC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE DEVICES WERE IMPLANTED IN 2006. ON APRIL 22, 2006, POST-OP X-RAY SHOWED THE LOCKING SCREWS APPEARED TO BE BROKEN AT THE PLATE/SCREW SHAFT INTERFACE. THE DEVICES WERE REVISED IN 2006.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM LOCKING SCREW | PERIARTICULAR SCREW | HWC | ZIMMER, INC. | NA | 60344727 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R |