FDA Adverse Event
Injury
Summary report: N
FEMORAL NAIL, A/R 10X380 MM
MDR report key: 2012891
·
Received March 1, 2011
Report
- Report Number
- 9610622-2011-00096
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- February 10, 2011
- Report Date
- February 16, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K021026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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
THE RISK MANAGER OF THE HOSPITAL REPORTED, THE DEVICE IMPLANTED IN (B)(6) 2010, AT THE HOSPITAL (B)(6), BROKE. THE PATIENT UNDERWENT A REVISION SURGERY IN (B)(6) 2011. THE DEVICE WAS REMOVED AND REPLACED BY ANOTHER DEVICE FROM A COMPETITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEMORAL NAIL, A/R 10X380 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | K111010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |