FDA Adverse Event
Other
Summary report: N
ASCENSION PIP
MDR report key: 478998
·
Received August 15, 2003
Report
- Report Number
- 1651501-2003-00024
- Event Type
- Other
- Date Received
- August 15, 2003
- Date of Event
- July 11, 2003
- Report Date
- August 13, 2003
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KWF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DEVICE THAT WAS IMPLANTED IN THE LEFT INDEX PIP JOINT WAS A LITTLE TOO SMALL, SO IT WAS REMOVED AND REPLACED WITH THE NEXT LARGER SIZE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION PIP | TOTAL FINGER JOINT IMPLANT | KWF | ASCENSION ORTHOPEDICS, INC. | PIP-200 | 02-232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |