FDA Adverse Event
Injury
Summary report: N
LEIBINGER PRIMARY RECONSTRUCTION PLATE
MDR report key: 1297487
·
Received January 27, 2009
Report
- Report Number
- MW5009763
- Event Type
- Injury
- Date Received
- January 27, 2009
- Date of Event
- January 8, 2009
- Report Date
- January 27, 2009
- Manufacturer
- STRYKER CRANIOMAXILLFACIAL
- Product Code
- GXN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
LEIBINGER PRIMARY RECONSTRUCTION PLATE BROKE NECESSITATING SURGERY FOR REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEIBINGER PRIMARY RECONSTRUCTION PLATE | NONE | GXN | STRYKER CRANIOMAXILLFACIAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Hospitalization |