BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTINCT JAVA BLOCKER

    MDR report key: 3180218 · Received June 13, 2013

    Report

    Report Number
    3003853072-2013-00044
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL RELEVANT INFO WILL BE PROVIDED WHEN THE DEVICE EVAL IS COMPLETED. SAME CASE AS: 3003853072-2013-00042, 3003853072-2013-00050, 3003853072-2013-00047, 3003853072-2013-00051, 3003853072-2013-00045, 3003853072-2013-00048, 3003853072-2013-00043, 3003853072-2013-00046, 3003853072-2013-00049.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BLOCKERS HAD BACKED OUT POST-OPERATIVELY. THE PT ORIGINALLY UNDERWENT SURGERY TO TREAT L3-L5 WITH DYNESYS INSTRUMENTATION. SUBSEQUENTLY, THE PT 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 PT EXPERIENCED A PULMONARY EMBOLISM AND COMPLAINED OF BACK PAIN. THE HOSP CONFIRMED THAT THERE WAS NO CAUSE AND EFFECT RELATION BETWEEN THE 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
    268077 INSTINCT JAVA BLOCKER BLOCKER NKB ZIMMER SPINE 046W0AN00002 E61868

    Patients

    Seq Age Sex Outcome Treatment
    1