BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW EXTENDER (STAINLESS STEEL)

    MDR report key: 4936714 · Received July 23, 2015

    Report

    Report Number
    2027467-2015-00168
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 3, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF BOTH SUSPECT DEVICES (SCREW EXTENDER) FOUND NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE INSTRUMENTS WERE FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. ALTHOUGH THE DEVICES WERE PROPERLY MANUFACTURED, ADDITIONAL INVESTIGATION WAS CONDUCTED TO DETERMINE ROOT CAUSE. THE ANALYSIS SHOWED THAT THE FAILURE MODE OBSERVED IN THIS EVENT WAS DUE TO IMPARTING EXCESSIVE TORSIONAL LOADS TO THE MATING INSTRUMENT (REDUCER) DURING THE ROD REDUCTION MANEUVER. EXCESSIVE LOAD CAN BE APPLIED DUE TO A TOLERANCE GAP CONDITION BETWEEN THE REDUCER AND EXTENDERS. THE OVER-TORQUE OBSERVATION WAS CORROBORATED BY THE TWO DESIGN INTERFACE ANALYSES (DIAS) THAT WERE PERFORMED ON THE REDUCER/SCREW EXTENDER INTERFACES. CORRECTIVE ACTION HAS BEEN IMPLEMENTED. THE DESIGN OF THE MATING INSTRUMENT (REDUCER) HAS BEEN UPGRADED/ IMPROVED TO ELIMINATE THE GAP POTENTIAL WHICH RESULTS IN THE OVER-STRESS OF THE SCREW EXTENDERS AND TAB BREAKAGE. THE ILLICO MIS POSTERIOR FIXATION SYSTEM IS INTENDED TO FACILITATE THE SURGICAL CORRECTION OF NONCERVICAL SPINAL DEFORMITIES BY PROVIDING TEMPORARY INTERNAL FIXATION AND STABILIZATION DURING BONE GRAFT HEALING AND/OR FUSION MASS DEVELOPMENT. WHEN USED FOR A MINIMALLY INVASIVE POSTERIOR APPROACH ILLICO MIS INSTRUMENTATION IS USED IN CONJUNCTION WITH POLYAXIAL SCREW COMPONENTS. THE IMPLANTS ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (TI-6AL-4V ELI OR TI-6AL-4V). THE RODS ARE AVAILABLE IN COMMERCIALLY PURE (CP) TITANIUM AND/OR COBALT CHROME.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER (B)(6) REPORTED THAT "THE SIDE CLIP OF THE SCREW EXTENDER WAS FRACTURED. IN THIS CASE, SURGEON HAD USED THE SCREW EXTENDER ALIGNMENT GUIDE TO ATTACH THE EXTENDERS ON IMPLANTS. AND SURGEON ALSO HAD USED THE SCREW EXTENDER REMOVER TO REMOVE THE SCREW EXTENDER AT THE END OF THE SURGERY. BUT THIS EXTENDER STILL WAS DAMAGED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481211 SCREW EXTENDER (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 73724 6910803

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other