FDA Adverse Event
Injury
Summary report: N
POREX SURGICAL, INC.
MDR report key: 594723
·
Received November 29, 2004
Report
- Report Number
- 1057129-2004-00003
- Event Type
- Injury
- Date Received
- November 29, 2004
- Date of Event
- December 12, 2003
- Manufacturer
- POREX SURGICAL
- Product Code
- JAZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
JAW IMPLANT WAS REMOVED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POREX SURGICAL, INC. | POROUS POLYETHYLENE IMPLANT - CHIN/JAW | JAZ | POREX SURGICAL | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |