BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    MDR report key: 4210933 · Received October 29, 2014

    Report

    Report Number
    3005031160-2014-00012
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 28, 2014
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MAX
    PMA / PMN Number
    K131350
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE SURGEON WAS USING A 90 DEGREE MEDIAL THROUGH LATERAL APPROACH TO INSERT AND POSITION A 8MM TRIAL FOR CONFIRMATION OF IMPLANT SIZE. WHEN THE SURGEON BEGAN TO PULL THE 8MM TRIAL OUT OF THE SURGICAL SITE, THE TIP OF THE INSERTER BROKE OFF IN THE 8MM TRIAL. THE SURGEON TRIED TO PULL THE 8MM TRIAL OUT OF THE SURGICAL SITE WITH A FEW DIFFERENT INSTRUMENTS. THE SURGEON WAS ABLE TO REMOVE THE 8MM TRIAL WITH THE #6 RASP CHISEL. THE PATIENT WAS NOT INJURED AS A RESULT OF THE INSERTER TIP BREAKING OFF IN THE 8MM TRIAL OR DURING THE REMOVAL OF THE 8MM TRIAL FROM THE SURGICAL SITE. IT WAS REPORTED THAT THE PATIENT IS DOING VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694121 CALIX LUMBAR SPINAL IMPLANT SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR