BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEON CRX GWG

    MDR report key: 1491280 · Received October 1, 2009

    Report

    Report Number
    3007038372-2009-00005
    Event Type
    Injury
    Date Received
    October 1, 2009
    Date of Event
    September 14, 2009
    Report Date
    October 1, 2009
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS INC.
    Product Code
    HSB
    PMA / PMN Number
    K081832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS TREATED WITH THE SUBJECT DEVICE TO REPAIR A CLAVICLE FRACTURE. A REVISION SURGERY WAS LATER REQUIRED DUE TO LOSS OF FIXATION (PROBABLY ERRED IN PLACING THE DEVICE AND HEAVIER COMMINUTION THAN INITIALLY REALIZED BY DOCTOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVEON CRX GWG CLAVICLE INTRAMEDULLARY BONE FIXATION HSB SONOMA ORTHOPEDIC PRODUCTS INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK