BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE

    MDR report key: 3735852 · Received April 9, 2014

    Report

    Report Number
    0001811755-2014-01231
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE CARTRIDGE FROM THE ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE BROKE WHILE INJECTING THE CEMENT. IT WAS REPORTED THAT NOTHING FELL INTO THE SURGICAL SITE AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING BACK-UP EQUIPMENT. 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
    213720 ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 13296012

    Patients

    Seq Age Sex Outcome Treatment
    1