BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTELON

    MDR report key: 1084317 · Received July 30, 2008

    Report

    Report Number
    MW5007832
    Event Type
    Malfunction
    Date Received
    July 30, 2008
    Date of Event
    June 29, 2007
    Report Date
    July 25, 2008
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    KYI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ORIGINALLY TWO PROCEDURES PERFORMED AT THE HOSPITAL BOSTON. IMPLANT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTELON ARTELON KYI SMALL BONE INNOVATIONS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR