BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    MDR report key: 4888890 · Received July 2, 2015

    Report

    Report Number
    3005031160-2015-00008
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 2, 2015
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MAX
    PMA / PMN Number
    K131350
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS IN THE PROCESS OF BEING RETURNED AND WILL BE EVALUATED.

    Description of Event or Problem · 1

    DURING A DISC HERNIATION STABILIZATION PROCEDURE AT L4 - L5, WHILE TRIALING FOR CORRECT SIZE OF THE DISC SPACE, THE CALIX-T/P INSERTER BROKE OFF AT THE DISTAL THREADED TIP INSIDE THE TRIAL. THE SURGEON USED COMPETITOR PRODUCTS FROM CLINIC STOCK TO COMPLETE THE PROCEDURE. A SMALL PORTION OF THE THREADED TIP REMAINED IN THE TRIAL. THIS MALFUNCTION EVENT OCCURRED ON (B)(6) 2015 IN (B)(6). BOTH THE INSERTER AND THE TRIAL WERE SENT TO X-SPINE, SYSTEMS, INC. THESE PARTS HAVE NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. ONCE RECEIVED, THE RETURNED PARTS WILL BE INVESTIGATED AND, A FOLLOW-UP REPORT WILL BE COMPLETED AT THAT TIME.

    Description of Event or Problem · 1

    DURING A DISC HERNIATION STABILIZATION PROCEDURE AT L4 - L5, WHILE TRIALING FOR CORRECT SIZE OF THE DISC SPACE, THE CALIX-T/P INSERTER BROKE OFF AT THE DISTAL THREADED TIP INSIDE THE TRIAL. THE SURGEON USED CLINIC STOCK TO COMPLETE THE PROCEDURE. A SMALL PORTION OF THE THREADED TIP REMAINED IN THE TRIAL. THIS EVENT OCCURRED ON (B)(6) 2015 IN (B)(6). BOTH THE INSERTER AND THE TRIAL WERE SENT TO X-SPINE SYSTEMS, INC. THESE PARTS WERE RECEIVED ON (B)(6) 2015. THE PARTS WERE THEN INVESTIGATED, AND THIS FOLLOW-UP REPORT PREPARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432494 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 35 YR