FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
MDR report key: 3073293
·
Received April 23, 2013
Report
- Report Number
- 0009610622-2013-00006
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- December 27, 2012
- Report Date
- December 28, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS-KIEL
- Product Code
- HSB
- PMA / PMN Number
- K032244
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175677 | LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS-KIEL | K298915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |