BEUDAMED
    FDA Adverse Event Other Summary report: N

    MUH HEAD SZ. 19.0

    MDR report key: 4115123 · Received September 15, 2014

    Report

    Report Number
    1651501-2014-00046
    Event Type
    Other
    Date Received
    September 15, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KXE
    PMA / PMN Number
    K112481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE THIRD OF THREE REPORTS CONCERNING THE SAME SURGERY (SEE MFR REPORT 1651501-2014-00044 AND 1651501-2014-00045). IT WAS REPORTED THAT PRODUCT ID MUH-600-H190-WW WAS SENT TO THE COMPANY REP AND HAD EXPIRED PRIOR TO THE SURGERY DATE. THIS WAS NOTICED PRIOR TO THE SURGERY. THE DEVICE WAS NOT IN CONTACT WITH THE PT. A SPARE DEVICE WAS AVAILABLE AND WAS USED TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN SURGERY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569417 MUH HEAD SZ. 19.0 FIRSTCHOICE DRUJ KXE ASCENSION ORTHOPEDICS 10-1693

    Patients

    Seq Age Sex Outcome Treatment
    1