FDA Adverse Event
Malfunction
Summary report: N
BIONX IMPLANT
MDR report key: 235593
·
Received August 6, 1999
Report
- Report Number
- MW1016908
- Event Type
- Malfunction
- Date Received
- August 6, 1999
- Report Date
- August 6, 1999
- Manufacturer
- BIONX IMPLANTS, INC.
- Product Code
- MAI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WENT TO VEHICLE, LIFTED OPERATIVE SHOULDER AND FELT A POP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIONX IMPLANT Implant | BANKART TACK | MAI | BIONX IMPLANTS, INC. | * | 1528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other |