FDA Adverse Event Injury Summary report: N

PLASTIC CIRCULAR PLATE

MDR report key: 4080800 · Received September 5, 2014

Report

Report Number
MW5038116
Event Type
Injury
Date Received
September 5, 2014
Date of Event
July 25, 2014
Report Date
September 5, 2014
Manufacturer
TRIMED, INC.
Product Code
HRS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VT, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PT BROUGHT TO OPERATING ROOM FOR SYMPTOMATIC LOOSE HARDWARE OF THE LEFT WRIST. STATUS POST INTERCARPAL FUSION. REMOVAL OF TRIMED CIRCULAR PLATE AND SCREWS FRACTURED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
543360 PLASTIC CIRCULAR PLATE CIRCULAR PLASTIC PLATE HRS TRIMED, INC. C140701 811K

Patients

Seq Age Sex Outcome Treatment
1 65 YR Required Intervention