FDA Adverse Event
Injury
Summary report: N
PLUS SBG
MDR report key: 1249627
·
Received December 2, 2008
Report
- Report Number
- 9612771-2008-00128
- Event Type
- Injury
- Date Received
- December 2, 2008
- Report Date
- December 2, 2008
- Manufacturer
- SMITH & NEPHEW ORTHOPEDICS AG
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUS SBG | STEM | KWY | SMITH & NEPHEW ORTHOPEDICS AG | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |