BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

    MDR report key: 3092437 · Received May 3, 2013

    Report

    Report Number
    0001811755-2013-01008
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED WHEN THE DEVICES ARE RECEIVED AND AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED. NOT RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION FINDINGS, THE CLAIMED CONDITION WAS CONFIRMED. UPON RETURNED UNIT EVALUATION, CEMENT LEAKAGE WAS DETECTED BETWEEN THE LUER SPINDLE AND LUER HOUSING FROM THE EXTENSION TUBE ASSEMBLY. THE O-RING WAS PARTIALLY SHIFTED FROM THE GROOVE AND BROKEN CAUSING THE CEMENT TO LEAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPLEX SYSTEM WAS BEING USED IN A VERTEBROPLASTY PROCEDURE WHEN THE CEMENT WOULD NOT GO DOWN THE NEEDLE INTO THE VERTEBRAL BODY, AND CEMENT WAS SEEN LEAKING BETWEEN THE TWIST CAP OF THE SYRINGE EXTENSION. A BACK-UP DEVICE WAS USED WHEN THE EVENT OCCURED FOR A SECOND TIME. WHEN THE THIRD SET WAS OPENED, THE CEMENT WAS ABLE TO BE INJECTED. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPLEX SYSTEM WAS BEING USED IN A VERTEBROPLASTY PROCEDURE WHEN THE CEMENT WOULD NOT GO DOWN THE NEEDLE INTO THE VERTEBRAL BODY, AND CEMENT WAS SEEN LEAKING BETWEEN THE TWIST CAP OF THE SYRINGE EXTENSION. A BACK-UP DEVICE WAS USED WHEN THE EVENT OCCURRED FOR A SECOND TIME. WHEN THE THIRD SET WAS OPENED, THE CEMENT WAS ABLE TO BE INJECTED. THERE WERE NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194905 AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO TBC

    Patients

    Seq Age Sex Outcome Treatment
    1