BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOMA NAIL

    MDR report key: 1781693 · Received July 27, 2010

    Report

    Report Number
    MW5016869
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    May 14, 2010
    Report Date
    July 27, 2010
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, AN ORIF OF LEFT CLAVICLE FX WITH SONOMA WAVEON INTRAMEDULLARY NAIL. PT RETURNED ON (B)(6) 2010 TO HAVE THE NAIL REMOVED AFTER IT BROKE. FAILED DEVICE AND RETURNED TO SURGERY. SONOMA (B)(4). SINGLE USE PT DEVICE. REP. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONOMA NAIL NAIL HSB

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR