BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI 8.5MM POLYAXIAL SCREW ASSY, 40MM (TI-6AL-4V)

    MDR report key: 5150271 · Received October 14, 2015

    Report

    Report Number
    2027467-2015-00187
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    May 18, 2015
    Report Date
    September 17, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWP
    PMA / PMN Number
    K042673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE IS NOT POSSIBLE. THE IMPLANT WILL NOT BE RETURNED. A REVIEW OF THE DEVICE REVEALED NO ANOMALIES. THE IMPLANT APPEARS TO HAVE BEEN PROPERLY MANUFACTURED AND RELEASED ACCORDING TO DESIGN SPECIFICATIONS. IT WAS REPORTED THAT INTERBODY FIXATION HAD NOT BEEN PERFORMED. THIS LIKELY CAUSED THE IMPLANT TO FRACTURE AND BREAK DUE TO BEING EXPOSED TO FATIGUE STRESSES BEYOND THOSE FOR WHICH IT WAS DESIGNED OR INTENDED. THE CONSTRUCT WAS MORE THAN LIKELY CARRYING THE MAJORITY OF THE LOAD THROUGHOUT THE TIME OF IMPLANTATION WITH NO GRADUAL TRANSFER THAT WOULD BE ASSOCIATED WITH FUSION. AS THESE IMPLANTS ARE INTENDED FOR TEMPORARY STABILIZATION UNTIL FUSION OCCURS THEY DO NOT HAVE AN INDEFINITE LIFE AND WILL MOST LIKELY FAIL OVER TIME IF FUSION IS NOT ACHIEVED. THE INSTRUCTIONS FOR USE PROVIDES WARNINGS FOR THIS TYPE EVENT (REF INS-025): WARNINGS: THE SYSTEM IMPLANTS ARE USED ONLY TO PROVIDE TEMPORARY INTERNAL FIXATION DURING THE BONE FUSION PROCESS WITH THE ASSISTANCE OF A BONE GRAFT. A SUCCESSFUL RESULT MAY NOT BE ACHIEVED IN EVERY INSTANCE OF USE WITH THESE DEVICES. WITHOUT SOLID BONE FUSION, THESE DEVICES CANNOT BE EXPECTED TO SUPPORT THE SPINE INDEFINITELY AND MAY FAIL DUE TO BONE-METAL INTERFACE, ROD FAILURE OR BONE FAILURE. THE BENEFIT OF SPINAL FUSIONS UTILIZING ANY PEDICLE SCREW FIXATION SYSTEM HAS NOT BEEN ADEQUATELY ESTABLISHED IN PATIENTS WITH STABLE SPINES. WITHOUT SOLID BONE FUSION, THESE DEVICES CANNOT BE EXPECTED TO SUPPORT THE SPINE INDEFINITELY AND MAY FAIL DUE TO BONEMETAL INTERFACE, ROD FAILURE OR BONE FAILURE. INTRAOPERATIVE MANAGEMENT: BONE GRAFT MUST BE PLACED IN THE AREA TO BE FUSED AND GRAFT MATERIAL MUST EXTEND FROM THE UPPER TO THE LOWER VERTEBRAE BEING FUSED.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT DURING A SCHEDULED REMOVAL CASE ON (B)(6) 2015 A POLYAXIAL SCREW WAS FOUND FRACTURED APPROXIMATELY 15MM FROM THE HEAD OF THE SCREW. THE PROXIMAL SECTION OF THE IMPLANT WAS REMOVED WITHOUT ISSUE WHILE THE DISTAL THREADED PORTION REMAINS PROPERLY POSITIONED/ENTRAPPED WITHIN THE PATIENT'S VERTEBRAE. INTERBODY FIXATION WAS NOT PERFORMED DURING THE INITIAL IMPLANTATION OF THE ZODIAC FIXATION SYSTEM AT THE L3-L5 VERTEBRAL BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681097 TI 8.5MM POLYAXIAL SCREW ASSY, 40MM (TI-6AL-4V) KWP, MNH, MNI KWP ALPHATEC SPINE INC 62085-40 672889

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other