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).