BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IO FIX SCREW AND WASHER SYSTEM

    MDR report key: 2960250 · Received February 8, 2013

    Report

    Report Number
    3007289093-2013-00001
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 8, 2013
    Manufacturer
    EXTREMITY MEDICAL LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT REQUIRED REVISION SURGERY TO REMOVE HARDWARE BECAUSE OF NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53376 IO FIX SCREW AND WASHER SYSTEM SCREW, FIXATION, BONE HWC EXTREMITY MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention