FDA Adverse Event
Other
Summary report: N
ASCENSION PIP
MDR report key: 494346
·
Received November 4, 2003
Report
- Report Number
- 1651501-2003-00033
- Event Type
- Other
- Date Received
- November 4, 2003
- Date of Event
- October 1, 2003
- Report Date
- November 3, 2003
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KWF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DEVICE THAT WAS IMPLANTED IN THE LEFT LONG FINGER PIP JOINT WAS REMOVED AND REPLACED WITH ANOTHER DISTAL COMPONENT OF THE SAME SIZE AND A PROXIMAL COMPONENT OF THE NEXT LARGER SIZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION PIP | TOTAL FINGER JOINT IMPLANT | KWF | ASCENSION ORTHOPEDICS, INC. | PIP-200 | 02-979 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |