FDA Adverse Event
Malfunction
Summary report: N
TARGET DEVICE 295X163 MM
MDR report key: 1071830
·
Received July 8, 2008
Report
- Report Number
- 9610622-2008-00103
- Event Type
- Malfunction
- Date Received
- July 8, 2008
- Date of Event
- May 16, 2008
- Report Date
- June 11, 2008
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE SUBMITTED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY, SHE NOTED THAT THE SURGEON APPEARED TO HAVE PROBLEMS WITH THE DISTAL LOCKING OF THE TARGET DEVICE. IT WAS VERY DIFFICULT TO ADJUST. NEVERTHELESS THE SURGERY WAS COMPLETED WITH THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET DEVICE 295X163 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | KP1973 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |