FDA Adverse Event
Injury
Summary report: N
UNIVERSAL FEMORAL NAIL, STERILE, 14MM X 420MM
MDR report key: 200474
·
Received December 2, 1998
Report
- Report Number
- 2520274-1998-00089
- Event Type
- Injury
- Date Received
- December 2, 1998
- Date of Event
- October 14, 1997
- Report Date
- November 3, 1998
- Manufacturer
- SYNTHES USA
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
ON MAY 24, 1996, A FEMORAL NAIL WAS IMPLANTED INTO THE PATIENT. ON OCTOBER 9, 1997, IT WAS NOTED THAT THE NAIL HAD BROKEN. ON OCTOBER 14, 1997, THE BROKEN NAIL WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL FEMORAL NAIL, STERILE, 14MM X 420MM Implant | UNIVERSAL NAILS | HSB | SYNTHES USA | NA | 2025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |