BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOMED

    MDR report key: 1714180 · Received June 4, 2010

    Report

    Report Number
    MW5016223
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 4, 2010
    Manufacturer
    INNOMED INC
    Product Code
    HWK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TREPHINE BROKE DURING EXTRACTION OF ANKLE SCREW. DEVICE RECONSTRUCTED TO FULL POTENTIAL. NO PIECES MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOMED TREPHINE HWK INNOMED INC S0123

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR