FDA Adverse Event
Other
Summary report: N
ASCENSION PIP
MDR report key: 1321296
·
Received February 6, 2009
Report
- Report Number
- 1651501-2009-00008
- Event Type
- Other
- Date Received
- February 6, 2009
- Report Date
- February 6, 2009
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MULTIPLE IMPLANTS WERE REMOVED DURING ONE CASE; THEREFORE, THE FOLLOWING MDR REPORTS ALL CORRESPOND TO THIS EVENT: 1651501- 2009-009, 010.
Description of Event or Problem · 1
TWO PIP JOINTS WERE REVISED FOR REASONS UNKNOWN (2 PROXIMAL AND 1 DISTAL COMPONENTS).
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 | Other |