BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEON CRX GGW

    MDR report key: 1567002 · Received December 23, 2009

    Report

    Report Number
    3007038372-2009-00008
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    December 7, 2009
    Report Date
    December 22, 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

    EN4100 IMPLANTED 2009. REVISION SURGERY FIVE MONTHS LATER. A PT WAS TREATED WITH THE SUBJECT DEVICE TO REPAIR A CLAVICLE FRACTURE. THE DEVICE APPEARS BROKEN IN THE X-RAY. NO DETAILS ARE KNOWN. LACK OF HEALING. PT COMPLAINS OF PAIN. EXPLANT HAS BEEN REQUESTED. MOST PROBABLE CAUSE IS PT NONCOMPLIANCE WITH POST-OP MOBILITY RESTRICTIONS.

    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