FDA Adverse Event
Other
Summary report: N
ASCENSION PIP
MDR report key: 1023755
·
Received March 24, 2008
Report
- Report Number
- 1651501-2008-00009
- Event Type
- Other
- Date Received
- March 24, 2008
- Date of Event
- February 11, 2008
- Report Date
- March 24, 2008
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KWF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVISION SURGERY WAS NOT THE RESULT OF IMPLANT FAILURE, BUT SURGICAL TECHNIQUE ERROR. DEVICE WAS NOT REMOVED.
Description of Event or Problem · 1
SURGEON EXAMINED X-RAY OF PATIENT POST-OP AND THOUGHT IMPLANT WAS BROKEN, BUT WAS MISTAKEN. REVISION SURGERY WAS PERFORMED TO REPOSITION THE SAME IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION PIP | TOTAL FINGER JOINT IMPLANT | KWF | ASCENSION ORTHOPEDICS, INC. | PIP-200 | 07/0407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |