FDA Adverse Event
Injury
Summary report: N
ANKLE ARTHRODESIS NAIL, LEFT T2 ANKLE Ø11X150MM
MDR report key: 3092522
·
Received May 3, 2013
Report
- Report Number
- 0009610622-2013-00008
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- January 8, 2013
- Report Date
- January 8, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-KIEL
- Product Code
- HSB
- PMA / PMN Number
- K051590
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195695 | ANKLE ARTHRODESIS NAIL, LEFT T2 ANKLE Ø11X150MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS-KIEL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Female | Required Intervention |