BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 12096739 · Received June 30, 2021

    Report

    Report Number
    3006179046-2021-00324
    Event Type
    Injury
    Date Received
    June 30, 2021
    Report Date
    June 29, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    UDI-DI
    00812258026295
    PMA / PMN Number
    K171791
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS A160217-24 AND A160301-09 WERE PROVIDED. IT IS UNKNOWN WHICH LOT NUMBER PERTAINS TO THIS EVENT. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE ROD WAS FOUND TO BE BROKEN DURING A CLINIC VISIT. THE ROD WAS ALREADY FULLY DISTRACTED. THE SURGEON OPTED TO LEAVE THE ROD IMPLANTED AND STABILIZED IT BY PLACING A DOMINO CONNECTOR TO THE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988357 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM - MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MS1-4590S UNKNOWN 00812258026295

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization