BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    MDR report key: 5057571 · Received September 4, 2015

    Report

    Report Number
    3005031160-2015-00010
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    July 29, 2015
    Report Date
    October 2, 2015
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MAX
    PMA / PMN Number
    K131350
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP 001 REPORT HAS A CORRESPONDING INITIAL 30-DAY REPORT THAT WAS SUBMITTED ON 08/28/2015 WITH THE REPORT #3005031160-2015-00010.

    Description of Event or Problem · 1

    DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) PROCEDURE, THE THREADED DISTAL END OF THE CALIX INSERTER WAS BROKEN LEAVING THE TRIAL PORTION IN THE PATIENT. THERE WAS NO INJURY TO THE PATIENT DUE TO THE INCIDENT.

    Description of Event or Problem · 1

    THE SURGEON WAS ABLE TO REMOVE THE TRIAL AND COMPLETE THE PROCEDURE WITH NO SIGNIFICANT SURGICAL DELAY AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590035 CALIX LUMBAR SPINAL IMPLANT SYSTEM LUMBAR SPINAL FUSION IMPLANT SYSTEM MAX X-SPINE SYSTEMS, INC. X034-0015 2029-01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other