BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEON CRX GGW

    MDR report key: 1522783 · Received November 4, 2009

    Report

    Report Number
    3007038372-2009-00006
    Event Type
    Injury
    Date Received
    November 4, 2009
    Date of Event
    October 7, 2009
    Report Date
    November 4, 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 PT WAS TREATED WITH THE SUBJECT DEVICE TO REPAIR A CLAVICLE FRACTURE. ON A F-U X-RAY, THE DEVICE WAS OBSERVED AS BROKEN WITH A SINGLE FRAGMENT. THE PT IS REPORTED AS HEALING SLOWLY, AND THE PHYSICIAN IS MONITORING THE PT TO MAKE SURE THE FRAGMENT DOES NOT MIGRATE. REVISION SURGERY IS NOT PLANNED. IT IS UNK WHAT EVENT LED TO THE DEVICE FAILING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK