BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIX SPINAL IMPLANT SYSTEM

    MDR report key: 3584068 · Received January 21, 2014

    Report

    Report Number
    3005031160-2014-00002
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 3, 2013
    Report Date
    January 20, 2014
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    ODP
    PMA / PMN Number
    K083637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A TLIF PROCEDURE AT L4-5, WHILE THE SURGEON WAS TRYING TO INSERT THE CALIX T-LIFT (7MM) PC INTO THE PATIENT, THE IMPLANT BROKE IN TO 3 DIFFERENT PIECES. THE SURGEON COULD NOT COMPLETE THE SURGERY WITH THE BROKEN CALIX T-LIFT (7MM) PC AND DID NOT HAVE A BACK-UP CALIX T-LIFT (7MM) PC ON HAND. THEREFORE, THE SURGEON USED A COMPETITOR'S PRODUCT (I.E. CAGE) AND COMPLETE THE SURGERY WITHOUT INCIDENT. THIS WAS THE FIRST TIME THE SURGEON USED THE CALIX SPINAL IMPLANT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49484 CALIX SPINAL IMPLANT SYSTEM CERVICAL INTERVERTEBRAL FUSION DEVICE, THORACOLUMBAR VERTEBRAL BODY REPLACEMENT ODP X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other