FDA Adverse Event
Malfunction
Summary report: N
IM REAMER, MOD. TRINKLE FIXING BIXCUT Ø8,0X480MM
MDR report key: 3020045
·
Received March 25, 2013
Report
- Report Number
- 0009610622-2013-00014
- Event Type
- Malfunction
- Date Received
- March 25, 2013
- Date of Event
- January 4, 2013
- Report Date
- January 4, 2013
- Manufacturer
- STRYKER OSTEOSYNTHESIS-KIEL
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
- Health Professional
- *
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122911 | IM REAMER, MOD. TRINKLE FIXING BIXCUT Ø8,0X480MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS-KIEL | K290959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |