BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

    MDR report key: 6125768 · Received November 23, 2016

    Report

    Report Number
    3005031160-2016-00088
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    April 19, 2016
    Report Date
    November 23, 2016
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    OVE
    PMA / PMN Number
    K131951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    AN ACDF AT C5 TO C6 WAS PERFORMED ON (B)(6) 2016 USING IRIX-C CERVICAL IMPLANT AND SELF DRILLING SCREWS. THE SURGEON'S REPRESENTATIVE REPORTED THAT HE PERFORMED A REVISION SURGERY ON (B)(6) 2016. THE REVISION WAS PERFORMED DUE TO THE SURGEON OBSERVING SUBSIDENCE AND THE PATIENT REPORTING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777413 IRIX-C CERVICAL INTEGRATED FUSION SYSTEM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention