FDA Adverse Event
Other
Summary report: N
ASCENSION PIP
MDR report key: 1350676
·
Received January 2, 2009
Report
- Report Number
- 1651501-2009-00002
- Event Type
- Other
- Date Received
- January 2, 2009
- Report Date
- January 2, 2009
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PIP PROXIMAL COMPONENT FRACTURED POST-OP. BOTH IMPLANTS WERE REMOVED AND A PMMA-SPHERE WAS USED AS A SPACER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION PIP | TOTAL FINGER JOINT IMPLANT | KYJ | ASCENSION ORTHOPEDICS, INC. | PIP-200 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |