BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXLE INTERSPINOUS FUSION SYSTEM

    MDR report key: 6871423 · Received September 17, 2017

    Report

    Report Number
    3005031160-2017-00155
    Event Type
    Malfunction
    Date Received
    September 17, 2017
    Date of Event
    July 5, 2017
    Report Date
    September 15, 2017
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A DRIVER BROKEN AT THE DISTAL TIP WAS RECEIVED AND VISUALLY EVALUATED. IT WAS REPORTED BY THE REPRESENTATIVE THAT THE SURGEON ELECTED TO NOT USE THE AVAILABLE TORQUE LIMITING HANDLE WHEN USING THE DRIVER. NOT USING THE TORQUE LIMITING HANDLE WHEN APPLYING TORQUE WITH THE DRIVER CAN CAUSE AN OVER TORQUE CONDITION RESULTING IN TIP BREAKAGE.

    Description of Event or Problem · 1

    REPORTED AS TWO WORN AXLE DRIVERS, BUT WHEN DRIVERS WERE RECEIVED ONE DRIVER WAS BROKEN, LOT # 050208, AT THE DISTAL TIP AND THE OTHER DRIVER WAS TWISTED/STRIPPED. BREAKAGE AND DAMAGE HAPPENED ON 7-5-17 DURING SCREW PLACEMENT. REPRESENTATIVE RESPONDED THAT SURGEON DIDN'T USE THE AVAILABLE TORQUE LIMITING HANDLE WHEN USING THE DRIVERS, BUT THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651178 AXLE INTERSPINOUS FUSION SYSTEM SCREWDRIVER, AXLE SYSTEM HXX X-SPINE SYSTEMS, INC. X060-0320 050208

    Patients

    Seq Age Sex Outcome Treatment
    1 Other