FDA Adverse Event
Injury
Summary report: N
14MM UNIVERSAL FEMORAL
MDR report key: 376691
·
Received February 15, 2002
Report
- Report Number
- 1719045-2002-00013
- Event Type
- Injury
- Date Received
- February 15, 2002
- Date of Event
- April 5, 2001
- Report Date
- January 11, 2002
- Manufacturer
- SYNTHES (USA)
- Product Code
- JDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
A NAIL, IMPLANTED IN 1996 DURING REVISION OF 18 MONTH ATROPHIC NON-UNION, BROKE POST OPERATIVE. NAIL WAS NOTED BROKEN 4 YEARS AFTER IMPLANTATION. BROKEN NAIL WAS REMOVED, WAS NOT REVISED.
Description of Event or Problem · 1
SUBJECT NAIL WAS IMPLANTED FOR A CLOSED COMMINUTED FEMORAL SHAFT FRACTURE OF THE RIGHT FEMUR ON 7/25/1996. PT UNDERWENT REVISION SURGERY ON 10/14/1996 TO ADD ILIAC CREST BONE GRAFT AND SUBJECT NAIL WAS LEFT IN PLACE. X-RAYS TAKEN ON 12/7/1998 SHOWED COMPLETE UNION OF FEMORAL FRACTURE AND ALL HARDWARE IN TACT AND WITHOUT FRACTURE. ON 2/12/2001 SURGEON SUGGESTED PT HAVE THE NAIL REMOVED. DURING REMOVAL ON 4/4/01 OR 4/5/2001 THE NAIL WAS NOTED TO BE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 14MM UNIVERSAL FEMORAL | UNIVERSAL NAILS | JDS | SYNTHES (USA) | NA | 2056 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention | LOCKING BOLTS. |