BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

    MDR report key: 3110572 · Received May 14, 2013

    Report

    Report Number
    0001811755-2013-01106
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 17, 2013
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE RETURNED UNIT EVALUATION, THE CLAIMED CONDITION WAS CONFIRMED. CEMENT WAS OBSERVED TO LEAK BETWEEN DELIVERY PISTON AND INJECTOR. THE MOST PROBABLE ROOT CAUSES FOR THIS TYPE OF CEMENT LEAKAGE CAN BE ASSOCIATED BUT NOT LIMITED TO THE FOLLOWING: CEMENT RELATED; MECHANICAL PROPERTIES ISSUE. IMPROPER FIT WITH RECIPROCATING SEAL AND INJECTION RESERVOIR. USER OPERATED THE CEMENT INJECTOR PRIOR TO COMPLETE TRANSFER CAUSING THE CEMENT LEAKAGE OBSERVED ONTO THE THREADS OF THE DELIVERY PISTON.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CEMENT WAS LEAKING OUT OF THE MIDDLE OF THE INJECTOR OF THE AUTOPLEX SYSTEM DURING A PROCEDURE. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CEMENT WAS LEAKING OUT OF THE MIDDLE OF THE INJECTOR OF THE AUTOPLEX SYSTEM DURING A PROCEDURE. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212450 AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 13053022

    Patients

    Seq Age Sex Outcome Treatment
    1