FDA Adverse Event
Malfunction
Summary report: N
DRILL, AO, STERILE 4, 2X340 MM
MDR report key: 1864992
·
Received October 5, 2010
Report
- Report Number
- 9610622-2010-00432
- Event Type
- Malfunction
- Date Received
- October 5, 2010
- Date of Event
- September 22, 2010
- Report Date
- September 22, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, OPEN BOX AND PLASTIC PACKAGING WAS MELTED. OPENED NEW DRILL BIT BOX.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRILL, AO, STERILE 4, 2X340 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K290869 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |