FDA Adverse Event
Malfunction
Summary report: N
FEMORAL NAIL, A/R 12X400 MM
MDR report key: 2212101
·
Received July 8, 2011
Report
- Report Number
- 9610622-2011-00306
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 21, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K022461
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED TO BY THE KIT AND CONSIGNMENTS MANAGER, THAT "THE DEVICES GOT BLOCKED".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEMORAL NAIL, A/R 12X400 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K122139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |