FDA Adverse Event
Other
Summary report: N
TRUFIT BGS PLUG
MDR report key: 1051299
·
Received May 22, 2008
Report
- Report Number
- 1651491-2008-00004
- Event Type
- Other
- Date Received
- May 22, 2008
- Report Date
- May 1, 2008
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- MQV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT UNDERWENT MICROFRACTURE AND DEBRIDEMENT CHONDROPLASTY IN 2006; POOR OUTCOME. SECOND SURGERY WAS DONE IN 2007 WITH (2) 7MM X 15MM TRUFIT PLUGS; POOR OUTCOME. UNDERWENT REVISION, DEBRIDEMENT, EVACUATION AND REVISION RESURFACING WITH AUTOGRAFT OATS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFIT BGS PLUG | TRUFIT | MQV | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |