FDA Adverse Event
Summary report: N
ARTHREX
MDR report key: 2756147
·
Received September 19, 2012
Report
- Report Number
- MW5027001
- Date Received
- September 19, 2012
- Date of Event
- August 28, 2012
- Report Date
- September 10, 2012
- Manufacturer
- ARTHREX
- Product Code
- MAI
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
EXPIRED DEVICE, MINI BIO PUSH LOCK ARTHREX IMPLANTED IN RIGHT WRIST. REASON FOR USE: TENDER SUBLUXING EXT CARPI ULNARIS. EXPIRED DEVICES IMPLANTED ON (B)(6) 2012. DEVICES EXPIRED ON 07/2012 AND 08/2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTHREX | MINI PUSH BIOLOCK 2.5 MM X 8 MM | MAI | ARTHREX | 349568 | ||
| 2 | ARTHREX | MINI PUSH BIOLOCK 2.5MM X 8MM | MAI | ARTHREX | 328326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |