BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

    MDR report key: 4192842 · Received October 22, 2014

    Report

    Report Number
    0001811755-2014-03716
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR EVALUATION, THEREFORE, THE REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. DEVICE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION HAS BEEN COMPLETED. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPLEX WAS BEING USED IN A PROCEDURE WHEN THE CEMENT WAS NOT TRANSFERRED PROPERLY RESULTING IN PROLONGATION OF THE PROCEDURE BY ONE HOUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK UP DEVICE WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPLEX WAS BEING USED IN A PROCEDURE WHEN THE CEMENT WAS NOT TRANSFERRED PROPERLY RESULTING IN PROLONGATION OF THE PROCEDURE BY ONE HOUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK UP DEVICE WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673513 AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES MIXER, CEMENT FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1