BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 VA CONDYLAR PLATE

    MDR report key: 3223589 · Received June 19, 2013

    Report

    Report Number
    3223589
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OUTRIGGER SLIPPED OFF THE PLATE AND WOULD NOT REPOSITION PROPERLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278381 4.5 VA CONDYLAR PLATE CONDYLAR PLATE FIXATION IMPLANT JDP SYNTHES USA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NO OTHER THERAPIES