FDA Adverse Event
Injury
Summary report: N
95 DEGREE DCS PLATE
MDR report key: 243443
·
Received October 7, 1999
Report
- Report Number
- 2520274-1999-00059
- Event Type
- Injury
- Date Received
- October 7, 1999
- Date of Event
- March 5, 1999
- Report Date
- September 9, 1999
- Manufacturer
- SYNTHES (USA)
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
PLATE WAS IMPLANTED IN 1998 FOR A NON-UNION OF A COMPOUND FRACTURE OF THE LEFT FEMUR PT SUFFERED IN A MOTOR VEHICLE ACCIDENT ON 09/25/1993. PLATE NOTED AS FRACTURED ON 02/17/1999 AND REMOVED ON 03/05/1999.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 95 DEGREE DCS PLATE Implant | DHS/DCS PLATES | HRS | SYNTHES (USA) | NA | 1397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention | SCREWS (11/20/1998 TO 03/05/1999). |