BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEON CRX

    MDR report key: 1905800 · Received November 19, 2010

    Report

    Report Number
    3007038372-2010-00013
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 11, 2010
    Manufacturer
    SONOMA ORTHOPEDIC PRODUCTS INC.
    Product Code
    HSB
    PMA / PMN Number
    K081832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS REMOVED DUE TO INFECTION AT SURGICAL SITE. ALTHOUGH PATIENT'S BONE IS HEALED, X-RAY SHOWS THAT THE IMPLANT IS BENT AND INCORRECTLY PLACED. PATIENT NON-COMPLIANCE, CONFIRMED BY PARENT'S STATEMENTS, LIKELY CONTRIBUTED TO BENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVEON CRX CLAVICLE INTRAMEDULLARY BONE FIXATION HSB SONOMA ORTHOPEDIC PRODUCTS INC. CU200410-04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK