BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

    MDR report key: 4932499 · Received July 22, 2015

    Report

    Report Number
    0001811755-2015-02690
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER BUT A PICTURE OF THE ACTUAL DEVICE WAS AND THEREFORE THE REPORTED EVENT WAS ABLE TO BE CONFIRMED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE BALLOON DID NOT FULLY INFLATE AND A CURETTE WAS USED TO CREATE A VOID. THE CEMENT WAS MIXED IN THE AUTOPLEX MIXER AND THE BLUE LID CAME OFF AND CEMENT FOAMED OUT. THE CEMENT APPEARED THICKER THAN NORMAL AND FOAMY. ANOTHER AUTOPLEX WAS USED AND THE LID CRACKED. A PRECISION CEMENT DELIVERY MIXER WAS USED AND WHILE MIXING, THE MIXER CRACKED DOWN THE SIDE. ANOTHER PRECISION CEMENT DELIVERY MIXER WAS USED AND THE CEMENT HARDENED WITHIN MINUTES AND WAS UNABLE TO USE. BACKUP CEMENT WAS USED AND THE CASE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THE OPERATING ROOM WAS COOLER THAN NORMAL. THERE WAS A 2 HOUR PROCEDURAL DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE BALLOON DID NOT FULLY INFLATE AND A CURETTE WAS USED TO CREATE A VOID. THE CEMENT WAS MIXED IN THE AUTOPLEX MIXER AND THE BLUE LID CAME OFF AND CEMENT FOAMED OUT. THE CEMENT APPEARED THICKER THAN NORMAL AND FOAMY. ANOTHER AUTOPLEX WAS USED AND THE LID CRACKED. A PRECISION CEMENT DELIVERY MIXER WAS USED AND WHILE MIXING, THE MIXER CRACKED DOWN THE SIDE. ANOTHER PRECISION CEMENT DELIVERY MIXER WAS USED AND THE CEMENT HARDENED WITHIN MINUTES AND WAS UNABLE TO USE. BACKUP CEMENT WAS USED AND THE CASE WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED THAT THE OPERATING ROOM WAS COOLER THAN NORMAL. THERE WAS A 2 HOUR PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474881 AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 13221012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BALLOON| UNKNOWN HV CEMENT