BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 12012591 · Received June 16, 2021

    Report

    Report Number
    3006179046-2021-00312
    Event Type
    Injury
    Date Received
    June 16, 2021
    Report Date
    June 16, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    PMA / PMN Number
    K171791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION HAS BEEN PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT PROXIMAL JUNCTIONAL KYPHOSIS (PJK) WAS OBSERVED AT PROXIMAL END OF CONSTRUCT. THE SURGEON WANTS TO CONVERT RIB TO SPINE IN EFFORT TO FIGHT PJK AND REVISE MAGEC RODS. AS PER REPORTER THE ROD WAS WORKING PROPERLY AND WAS MAXED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905682 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM - MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other