FDA Adverse Event Injury Summary report: N

PLATE, FIXATION, BONE

MDR report key: 3942122 · Received July 17, 2014

Report

Report Number
3025141-2014-00175
Event Type
Injury
Date Received
July 17, 2014
Report Date
June 20, 2014
Manufacturer
ACUMED LLC
Product Code
HRS
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IN, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

APPROXIMATELY FIVE YEARS AFTER IMPLANTATION, THE PATIENT EXPERIENCED FPL RUPTURE FOLLOWING VOLAR PLATING OF THE WRIST.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
418194 PLATE, FIXATION, BONE HRS ACUMED LLC

Patients

Seq Age Sex Outcome Treatment
1