FDA Adverse Event
Injury
Summary report: N
FEMORAL LOCKING NAIL SMALL DIA., LEFT D11X400 MM
MDR report key: 591883
·
Received April 13, 2005
Report
- Report Number
- 9610622-2005-00017
- Event Type
- Injury
- Date Received
- April 13, 2005
- Date of Event
- March 17, 2005
- Report Date
- March 23, 2005
- Manufacturer
- STRYKER TRAUMA KIEL
- Product Code
- HSB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
REPORTED BREAKAGE OF A GK NAIL WITH PSEUDARTHROSIS. THE PT REQUIRED A SECOND SURGERY TO REMOVE THE NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEMORAL LOCKING NAIL SMALL DIA., LEFT D11X400 MM | IMPLANT | HSB | STRYKER TRAUMA KIEL | NA | K588609 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |