BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 2233150 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02645
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 27, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CORE UNIVERSAL DRIVER WAS SENT IN FOR SERVICE AND IT RAN ON ITS OWN WITHOUT ACTIVATION DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE UNIVERSAL DRIVER HBE STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK