FDA Adverse Event
Other
Summary report: N
ASCENSION MCP
MDR report key: 1304788
·
Received February 3, 2009
Report
- Report Number
- 1651501-2009-00006
- Event Type
- Other
- Date Received
- February 3, 2009
- Report Date
- February 3, 2009
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KYJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LOT TRACE DEMONSTRATED THAT DEVICE MET ALL APPLICABLE MANUFACTURING SPECIFICATIONS.
Description of Event or Problem · 1
A FRACTURE WAS DISCOVERED IN THE DISTAL MCP COMPONENT IN POST-OP X-RAY. JOINT HAS NOT BEEN REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION MCP | TOTAL FINGER JOINT IMPLANT | KYJ | ASCENSION ORTHOPEDICS, INC. | MCP-100 (DISTAL) | 08-1203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |