BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UHEAD

    MDR report key: 3498991 · Received November 20, 2013

    Report

    Report Number
    3498991
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Date of Event
    June 13, 2013
    Report Date
    November 20, 2013
    Manufacturer
    SMALL BONE INNOVATIONS, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS BROUGHT IN BY MANUFACTURER REPRESENTATIVE AND WHEN THE BOX WAS OPENED THE IMPLANT WAS FOUND TO HAVE A HOLE IN THE INNER AND OUTER PACKAGE AND THE IMPLANT WAS NOT STERILE. IT WAS THEN DECIDED TO FLASH STERILIZE WITH A BIOLOGICAL IN A FLASH PAN OR PRE-VACUUM CYCLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601003 UHEAD PROSTHESIS, WRIST HRS SMALL BONE INNOVATIONS, INC. * 61301

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR