FDA Adverse Event
Injury
Summary report: N
SYNTHES
MDR report key: 1983758
·
Received February 1, 2011
Report
- Report Number
- MW5019337
- Event Type
- Injury
- Date Received
- February 1, 2011
- Date of Event
- March 1, 2010
- Report Date
- January 28, 2011
- Manufacturer
- SYNTHES INC
- Product Code
- HSB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AR, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
ON OR ABOUT (B)(6), 2010, I UNDERWENT SURGERY ON BOTH LEGS FOR COMPOUND FRACTURES. THE FEMORAL NAIL KIT THAT WENT IN THE LEFT FEMUR, THE SCREW ON THE LOWER PART OF FEMUR BROKE BEFORE 3 MONTHS WERE UP. I NOW HAVE 1 LEG SHORTER BECAUSE OF THIS. MORE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTHES | RETROGRADE FEMORAL KIT | HSB | SYNTHES INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Hospitalization| R| S |