BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

    MDR report key: 3811310 · Received May 15, 2014

    Report

    Report Number
    0001811755-2014-01762
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    NDN
    PMA / PMN Number
    K091606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF THE RETURNED UNIT, THE REPORTED CONDITION WAS CONFIRMED TO BE RELATED TO LID BREAKAGE. THE MIX CHAMBER¿S LID WAS FOUND BROKEN/FRACTURED AND THUS CEMENT LEAKED THRU THE MIX CHAMBER TOP. THE DEVICE WAS DISCARDED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE MIXER LID FROM THE AUTOPLEX SYSTEM BROKE, WHICH CAUSED A 30-45 MINUTE DELAY IN THE PROCEDURE. IT WAS REPORTED THAT NO ADDITIONAL ANESTHESIA WAS REQUIRED AND THAT THE PROCEDURE WAS COMPLETED UTILIZING BACK-UP EQUIPMENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE MIXER LID FROM THE AUTOPLEX SYSTEM BROKE, WHICH CAUSED A 30-45 MINUTE DELAY IN THE PROCEDURE. IT WAS REPORTED THAT NO ADDITIONAL ANESTHESIA WAS REQUIRED AND THAT THE PROCEDURE WAS COMPLETED UTILIZING BACK-UP EQUIPMENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290732 AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES CEMENT, BONE, VERTEBROPLASTY NDN STRYKER INSTRUMENTS-PUERTO RICO 13193012

    Patients

    Seq Age Sex Outcome Treatment
    1