BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST CHOICE HEAD 16.0-STEM 5.5

    MDR report key: 3181624 · Received June 14, 2013

    Report

    Report Number
    1651501-2013-00014
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KXE
    PMA / PMN Number
    K112481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    DURING SURGERY, WHEN IMPACTING THE DEVICE, THE SURGEON FELT THE HEAD ON THE IMPLANT WAS NOT THE SAME SIZE AS THE TRIAL DEVICE OR THE SIZE THE BOX (CONTAINING THE DEVICE) CLAIMED IT TO BE. A SECOND IMPLANT OF THE SAME SIZE AND LOT NUMBER WAS AVAILABLE WHICH WAS THE CORRECT SIZE AND WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PT INJURY. HOWEVER, THERE WAS A REPORTED 20 MIN DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271011 FIRST CHOICE HEAD 16.0-STEM 5.5 FIRSTCHOICE DRUJ KXE ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1