BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFUSE ROTATING SHAVER

    MDR report key: 5835344 · Received July 29, 2016

    Report

    Report Number
    3007617183-2016-00001
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    June 30, 2016
    Report Date
    July 29, 2016
    Manufacturer
    VERTEBRAL TECHNOLOGIES, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A 6MM SHAVER WAS INITIALLY USED IN THE PREPARATION OF THE DISC SPACE FOR USE OF THE INTERFUSE T INTERBODY FUSION DEVICE. THERE WERE NO ISSUES WITH THE USE OF THE 6MM SHAVER. WHEN A 7MM SHAVER WAS USED, IT BROKE INSIDE THE DISC SPACE AS IT WAS BEING ROTATED, LEAVING A PIECE OF THE SHAVER WITH SHARP EDGES IN THE DISC SPACE. THE AMOUNT OF FORCE USED DURING THE ROTATION OF THE SHAVER WAS DESCRIBED AS "NORMAL". THE BROKEN PIECE OF THE SHAVER WAS SUCCESSFULLY REMOVED AND THE SURGERY WAS CONTINUED AND AN INTERFUSE T INTERVERTEBRAL BODY FUSION DEVICE (REF (B)(4), LOT 140425-01) WAS IMPLANTED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487240 INTERFUSE ROTATING SHAVER PADDLE SHAVER LXH VERTEBRAL TECHNOLOGIES, INC. 9128-07 160210-02

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR