BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE

    MDR report key: 3923268 · Received July 9, 2014

    Report

    Report Number
    0001811755-2014-02442
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE USER FACILITY; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED MALFUNCTION WITHOUT AN EVALUATION OF THE DEVICE. THE DEVICE WAS DISCARDED BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE ACM CARTRIDGE BROKE. IT WAS REPORTED THAT NOTHING FELL INTO THE SURGICAL SITE AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING THE SAME DEVICE. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401663 ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-KALAMAZOO 14076012

    Patients

    Seq Age Sex Outcome Treatment
    1 SIMPLEX P-(B)(4) TWIN PACK 61910002 ((B)(4))