BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXLE INTERSPINOUS FUSION SYSTEM

    MDR report key: 6926124 · Received October 7, 2017

    Report

    Report Number
    3005031160-2017-00159
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Report Date
    October 6, 2017
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWP
    PMA / PMN Number
    K101471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL AXLE IMPLANT WAS NOT RETURNED FOR EVALUATION AND LOT # IS NOT KNOWN. REPRESENTATIVE IMPLANT OF THE SAME SIZE WAS PULLED FROM THE RETURNING TRAY FOR TESTING (LOT # 199279). THIS AXLE IMPLANT WAS FOUND TO BE WITHIN SPECIFICATION. TORQUE LIMITING HANDLE USED WAS ALSO TESTED. THIS TLH WAS ALSO FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    ON 09/06/2017 A REPORT WAS RECEIVED OF ALLEGED MIGRATION. A 36 MM NO INSERT AXLE IMPLANT WAS IMPLANTED DURING AN UNSPECIFIED AXLE FUSION PROCEDURE, DATE NOT PROVIDED. IT IS ALLEGED THAT THE AXLE IMPLANT HAS DISASSOCIATING, OR MIGRATED, AN UNKNOWN DISTANCE, AFTER AN UNSPECIFIED AMOUNT OF TIME, POST IMPLANTATION. TWO AXLE IMPLANTS WERE ALREADY PRESENT ABOVE AND BELOW THE AXLE IMPLANT OF INTEREST AT THE TIME OF IMPLANTATION. THE AXLE IMPLANT WAS IMPLANTED IN THE MIDDLE LOCATION FOR THREE TOTAL IMPLANTS. NO REVISIONS PLANNED. NO EXPLANTED PARTS COMING BACK, HOWEVER REPRESENTATIVE IMPLANT OF THE SAME SIZE WAS PULLED FROM THE RETURNING TRAY FOR TESTING (LOT # 199279). TORQUE LIMITING HANDLE USED WAS ALSO TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705596 AXLE INTERSPINOUS FUSION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP X-SPINE SYSTEMS, INC. X060-0241

    Patients

    Seq Age Sex Outcome Treatment
    1 Other