BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW EXTENDER (STAINLESS STEEL)

    MDR report key: 5021600 · Received August 21, 2015

    Report

    Report Number
    2027467-2015-00177
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 21, 2015
    Report Date
    August 5, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE (SCREW EXTENDER) FOUND NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. THE INSTRUMENT WAS FOUND TO BE PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. ALTHOUGH THE DEVICE WAS 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 NON-CERVICAL 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 ((B)(4)). THE RODS ARE AVAILABLE IN COMMERCIALLY PURE (CP) TITANIUM AND/OR COBALT CHROME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY COULD NOT GET THE EXTENDER TO RELEASE FROM THE SCREW. THE SURGEON NOTICED THAT THE SLEEVE WAS WEDGED NEXT TO BONE AND WOULD NOT ALLOW THE TAB TO RELEASE, SO HE USED A SMALL CURVED CURETTE TO LEVERAGE THE TAB CAUSING IT TO BREAK OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554727 SCREW EXTENDER (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 73772 6706101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other