FDA Adverse Event
Other
Summary report: N
ASCENSION MCP
MDR report key: 481704
·
Received August 27, 2003
Report
- Report Number
- 1651501-2003-00028
- Event Type
- Other
- Date Received
- August 27, 2003
- Date of Event
- July 23, 2003
- Report Date
- August 27, 2003
- Manufacturer
- ASCENSION ORTHOPEDICS, INC.
- Product Code
- KWF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AT 2 1/2 MONTHS POST-OP, THE IMPLANT WAS DISLOCATED AND WAS REMOVED AND REPLACED WITH A SILICONE SPACER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSION MCP | TOTAL FINGER JOINT IMPLANT | KWF | ASCENSION ORTHOPEDICS, INC. | MCP-100 | A34701F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |