BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    MDR report key: 5065666 · Received September 9, 2015

    Report

    Report Number
    3005031160-2015-00011
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 10, 2015
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MAX
    PMA / PMN Number
    K131350
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    REPORTED VIA E-MAIL THAT DURING A TLIF PROCEDURE USING THE CALIX INSERTER AND 13MM TRIAL, THE TRIAL WAS BROKEN OFF THE THREADED TIP OF THE INSERTER DURING INSERTION. A PIECE OF THE THREADED TIP REMAINED WITHIN THE TRIAL. THERE WAS NO INJURY TO THE PATIENT AND NO SIGNIFICANT SURGICAL DELAY DUE TO THE INCIDENT.

    Description of Event or Problem · 1

    THE CALIX INSERTER AND CALIX SYSTEM 13MM TILF TRIAL WERE AVAILABLE FOR INVESTIGATION ON (B)(6) 2015. UPON VISUAL INSPECTION. X-SPINE CONFIRMED THAT THE DISTAL END OF THE INSERTER WAS BROKEN AT THE TIP AS INDICATED BY THE COMPLAINANT. UPON VISUAL INSPECTION, X-SPINE CONFIRMED THAT THE HOLE LOCATED ON THE 13MM TRIAL CONTAINED A PORTION OF THE INSERTER TIP WHICH HAD BROKEN OFF, AS INDICATED BY THE COMPLAINANT. THE INSERTER AND THE TRIAL WERE INSPECTED AND MEASURED AGAINST THEIR ENGINEERING DRAWINGS AND BOTH WERE FOUND TO MEET ALL SPECS, INCLUDING THE DIMENSIONS OF THE TRIAL'S RECEIVING HOLE WHICH WERE ALSO FOUND TO MEET SPECS MEASURED. ACCORDING TO THE CALIX SPINAL IMPLANT SYSTEM - INFO FOR USE (IFU) - INTRAOPERATIVE MANAGEMENT (STEPS 3 AND 4). "IMPLANTS SHOULD BE ATTACHED TO THE CORRESPONDING INSERTER SUCH THAT THEY ARE FULLY SEALED ON THE INSERTER. CARE SHOULD BE TAKEN NOT TO OVER-TIGHTEN THE IMPLANT TO THE INSERTER. IMPLANTS SHOULD NOT BE AXIALLY ROTATED WITH THE INSERTER ONCE THEY HAVE BEEN IMPLANTED. THIS MAY LEAD TO DAMAGE OF THE IMPLANT AND/OR THE INSERTER." THE CALIX TRIAL WITH THE THREADED TIP OF THE INSERTER BROKEN OFF WITHIN (THE TRIAL) HAS A LARGE AMOUNT OF SCRATCHES AND DISFIGURATION ALONG THE ANTERIOR AND POSTERIOR SIDES (TOP AND BOTTOM) OF THE TRIAL. A TRIAL THAT IS NOT FULLY SEATED ON THE INSERTER DURING USE IS THE MOST LIKELY CAUSE OF THIS TYPE OF DAMAGE. THE MALFUNCTION OF THE INSERTER TIP BREAKING WITHIN THE TRIAL CAN BE REPLICATED WITH AXIALLY ROTATION OF THE INSERTER WITH ATTACHED TRIAL WHILE INSIDE THE SURGICAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595546 CALIX LUMBAR SPINAL IMPLANT SYSTEM LUMBAR SPINAL FUSION IMPLANT SYSTEM MAX X-SPINE SYSTEMS, INC. X034-0015 836597

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other