BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-C CERVICAL INTEGRATED FUSION SYSTEM

    MDR report key: 4150990 · Received October 8, 2014

    Report

    Report Number
    3005031160-2014-00010
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    OVE
    PMA / PMN Number
    K131951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 10/08/14.(B)(4): DEVICE IS STILL IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE WAS CONTACTED BY A DOCTOR FROM (B)(6). THE DOCTOR HAD REPORTED, A POSTOPERATIVE X-RAY PURPORTEDLY REVEALS A SCREW THAT MAY BE BACKING OUT ON AN IRIX-C IMPLANT. THE PATIENT IS ASYMPTOMATIC AND THE DOCTOR PLANS TO MONITOR THE PATIENT, WITH NO PLAN FOR REVISION SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633122 IRIX-C CERVICAL INTEGRATED FUSION SYSTEM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL, PRODUCT OVE X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1