FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL TORQUE LIMITING ATTACHMENT AXSOS AO FIT
MDR report key: 2020524
·
Received February 16, 2011
Report
- Report Number
- 8031020-2011-00043
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 1, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, TORQUE LIMITER BROKE INTRO OPERATIVELY. FLASHED ANOTHER ONE TO GET THROUGH SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL TORQUE LIMITING ATTACHMENT AXSOS AO FIT | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |