FDA Adverse Event Death Summary report: N

THORP PLATE

MDR report key: 287477 · Received July 31, 2000

Report

Report Number
2520274-2000-00040
Event Type
Death
Date Received
July 31, 2000
Date of Event
April 16, 1999
Report Date
June 29, 2000
Manufacturer
SYNTHES USA
Product Code
HRS
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
SC, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PT WAS IMPLANTED WITH THE THORP PLATE IN 1996. THE PLATE WAS NOTED BROKEN IN 1999. THE PLATE WAS REMOVED ON AN UNKNOWN DATE.

Description of Event or Problem · 1

THE PLATE WAS REMOVED ON 6/17/99.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 THORP PLATE RECONSTRUCTION PLATE HRS SYNTHES USA NA NI

Patients

Seq Age Sex Outcome Treatment
1 73 YR Required Intervention UNKNOWN SCREWS (1996 TO NI).