BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE UNIVERSAL DRIVER

    MDR report key: 2702373 · Received August 9, 2012

    Report

    Report Number
    1811755-2012-03049
    Event Type
    Malfunction
    Date Received
    August 9, 2012
    Date of Event
    July 19, 2012
    Report Date
    July 23, 2012
    Manufacturer
    STRYKER INSTRUMENTS, INSTRUMENTS DIV.
    Product Code
    HBE
    PMA / PMN Number
    K032303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE VISUAL EXAMINATION, A NUMBER OF INTERNAL COMPONENTS WERE FOUND TO BE WORN INCLUDING THE FLEXES.

    Description of Event or Problem · 1

    THE CORE UNIVERSAL DRIVER WAS SENT FOR SERVICE AND IT DISPLAYED A BIAS CURRENT ERROR DURING PERFORMANCE TESTING AT THE MFR. 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, INSTRUMENTS DIV.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK