FDA Adverse Event
Malfunction
Summary report: N
LARGE AO COUPLING ASNIS III HALL FITTING
MDR report key: 1853820
·
Received September 29, 2010
Report
- Report Number
- 8031020-2010-00126
- Event Type
- Malfunction
- Date Received
- September 29, 2010
- Date of Event
- September 9, 2010
- Report Date
- September 10, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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, "THE CHUCK BECAME COLD WELDED TO THE CANNULATED DRILL AND WOULD NOT COME OFF."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LARGE AO COUPLING ASNIS III HALL FITTING | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | P19586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |