FDA Adverse Event
Injury
Summary report: N
SWANSON GREAT TOE IMPLANT WITH GROMMETS
MDR report key: 506963
·
Received January 16, 2004
Report
- Report Number
- 1043534-2004-00005
- Event Type
- Injury
- Date Received
- January 16, 2004
- Date of Event
- December 4, 2003
- Report Date
- December 16, 2003
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- KWD
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ORIG SURG. 2 YRS. AGO. ALLEGEDLY PT HAD RECENT REJECTION WITHOUT REACTIVE BONE CHANGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWANSON GREAT TOE IMPLANT WITH GROMMETS | SMALL JOINT COMPONENT | KWD | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |