BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGEC RODS

    MDR report key: 9166091 · Received October 8, 2019

    Report

    Report Number
    9166091
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    November 19, 2016
    Report Date
    September 13, 2019
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC
    Product Code
    PGN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS EARLY ONSET SCOLIOSIS AND ABNORMAL SPINE CORD. THE PATIENT UNDERWENT A POSTERIOR SPINAL INSTRUMENTATION IMPLANT APPROXIMATELY THREE YEARS AGO. THE IMPLANTS WERE STRYKER SCREWS BUT ELLIPSE 5.5 IMPLANTS AND ELLIPSE TECHNOLOGIES MAGEC 9 CM X 5.5 MM DIAMETER TITANIUM IMPLANTS, ELLIPSE 5.5MM STANDARD ROD WITH 90MM ACTUATOR'S LOT# A160620-03, ELLIPSE 5.5MM OFFSET ROD WITH 90MM ACTUATOR'S LOT# A150513-07-00-03U AND BONE GRAFTING POSTERIOR ARTHRODESIS T2, T3, T4 AND ALSO L1 AND L2 WITH 30 CC OF ALLOGRAFT. AFTER TWO ADJUSTMENTS OF THE RODS, THE PATIENT HAD THE RODS REMOVED DUE TO THE FAILURE OF THE RODS LENGTHENING TRANSCUTANEOUSLY. THE SAME PROVIDER INDICATED THAT THE HOSPITAL IS SEEING A POSSIBLE TREND WITH THESE RODS. THIS PATIENT UNDERWENT REMOVAL OF THE RODS LAST MONTH AND HAD REPLACEMENT WITH SOLERA 5.5 FIXED SCREWS AND 5.5 TITANIUM GROWING RODS WITH 90MM SOLERA CONNECTOR. NO COMPLICATIONS AND PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960960 MAGEC RODS SPINAL RODS PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC A160620-03 & A150513-07-00-3U

    Patients

    Seq Age Sex Outcome Treatment
    1 3650 DA