BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION SCREW EXTENDER (STAINLESS STEEL)

    MDR report key: 5663669 · Received May 18, 2016

    Report

    Report Number
    2027467-2016-00035
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    May 6, 2016
    Report Date
    May 6, 2016
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    UDI-DI
    00840967192901
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED A SECOND SCREW EXTENDER, LOT 7180101, MANUFACTURED ON (B)(6) 2014. AN EVALUATION OF THE RETURNED INSTRUMENTS (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.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER (B)(6) REPORTED THAT ONE OF THE WINGS ON BOTH ILLICO SCREW EXTENDERS ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319797 REDUCTION SCREW EXTENDER (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 73772 7169702 00840967192901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other