FDA Adverse Event
Injury
Summary report: N
SYNTHES
MDR report key: 81367
·
Received February 12, 1997
Report
- Report Number
- 81367
- Event Type
- Injury
- Date Received
- February 12, 1997
- Date of Event
- July 23, 1996
- Report Date
- July 26, 1996
- Manufacturer
- SYNTHES
- Product Code
- HSB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT HAS A HISTORY OF METASTIC CANCER OF THE BONE. PT WAS STANDING AFTER HEARING A SNAP. X-RAY REVEALED A EHP FRACTURE WITH FRACTURE THROUGH PATHOLOGIC LESION IN THE SUB-TROCHANTERIC REGION AND FRACTURE THROUGH THE FEMORAL NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTHES Implant | FEMORAL NAIL ORTHOPEDIC IMPLANT | HSB | SYNTHES | * | A3DX078 (MCN) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |