BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT JAVA MONOAXIAL PEDICLE SCREW

    MDR report key: 3180222 · Received June 13, 2013

    Report

    Report Number
    3003853072-2013-00048
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ZIMMER SPINE
    Product Code
    MNH
    PMA / PMN Number
    K113270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL RELEVANT INFORMATION WILL BE PROVIDED WHEN THE DEVICE EVALUATION IS COMPLETED. SAME CASE AS: 3003853072-2013-00042, 3003853072-2013-00050, 3003853072-2013-00044, 3003853072-2013-00047, 3003853072-2013-00051, 3003853072-2013-00045, 3003853072-2013-00043, 3003853072-2013-00046, 3003853072-2013-00049.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREWS HAD MOVED WITHIN THE BONE POST-OPERATIVELY. THE PATIENT ORIGINALLY UNDERWENT SURGERY TO TREAT L3-L5 WITH DYNESYS INSTRUMENTATION. SUBSEQUENTLY, THE PATIENT FELL CAUSING THE L5 SCREW TO BREAK AND PEDICLE TO FRACTURE. A REVISION SURGERY WAS PERFORMED TO REMOVE THE INSTRUMENTATION AND WAS REPLACED WITH INSTINCT JAVA INSTRUMENTATION AT L2-S1. NO SCREWS WERE IMPLANTED AT L5 DUE TO THE FRACTURE OF THE PEDICLE. FIFTEEN DAYS AFTER THE REVISION SURGERY, THE PATIENT EXPERIENCED A PULMONARY EMBOLISM AND COMPLAINED OF BACK PAIN. THE HOSPITAL CONFIRMED THAT THERE WAS NO CAUSE AND EFFECT RELATION BETWEEN INSTINCT JAVA INSTRUMENTATION AND THE PULMONARY EMBOLISM. X-RAY SHOWED THE BLOCKERS IN THE S1 SCREWS HAD BACKED OUT FROM THE SCREW HEADS AND THE RODS CAME OUT OF THE SCREWS. DURING REVISION SURGERY IT WAS DISCOVERED IN ADDITION TO THE S1 BLOCKERS BACKING OUT FROM THE SCREW HEADS, THE SCREWS AT L2 AND L3 HAD MOVED WITHIN THE BONE AND THE 4 BLOCKERS HAD BECOME PARTIALLY UNSCREWED FROM THE SCREWS AT L2 AND L3. THE INSTRUMENTATION AT L4 REMAINED INTACT. THE ENTIRE CONSTRUCT WAS REMOVED AND REPLACED WITH A COMPETITOR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544365 INSTINCT JAVA MONOAXIAL PEDICLE SCREW MONOAXIAL PEDICLE SCREW MNH ZIMMER SPINE 046W0AN38540 E51198

    Patients

    Seq Age Sex Outcome Treatment
    1 Male