BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT 8MM 8DEG 31X24MM

    MDR report key: 2478522 · Received February 21, 2012

    Report

    Report Number
    3008657535-2012-00014
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 21, 2012
    Manufacturer
    THEKEN SPINE LLC
    Product Code
    MAX
    PMA / PMN Number
    K080822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA¿S INVESTIGATION DETERMINED THAT THERE WERE NOT RELATED ANOMALIES IN THE DEVICE HISTORY RECORD. NO COMPLAINT SAMPLE WAS AVAILABLE FOR EVAL; THEREFORE, ROOT CAUSE ANALYSIS WAS NOT POSSIBLE. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A SPINAL SURGERY PROCEDURE, THE SURGEON WAS INSERTING AND APOD CAGE AT THE L5-S1 DISC SPACING USING A 31X24X8MM CAGE (21-TA-3108). HE NOTED THAT THE DISC SPACE WAS TIGHT. HE IS AWARE THAT WHEN THE HANDLE OF THE INSERTER BEGINS TO LOOSEN THERE IS A CHANCE THAT A CRACK IS DEVELOPING IN THE CAGE. THE SURGEON NOTED THE LOOSENING OF THE INSERTER, AND WHEN IT WAS REMOVED, A CRACK BEGAN AT THE INSERTER HOLE IN THE 3 O¿CLOCK POSITION AND RADIATED OBLIQUELY TOWARD THE TANTALUM MARKER TO THE END OF THE CAGE. THE PROCEDURE WAS PROLONGED BY ABOUT 20 MINUTES. THE CAGE REMAINED IN THE PT AS THE SURGEON WAS ALREADY PLANNING TO PERFORM A POSTERIOR FIXATION USING THE PEDICLE SCREW SYSTEM ON THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANT 8MM 8DEG 31X24MM VU-APOD MAX THEKEN SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1