BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 12012666 · Received June 16, 2021

    Report

    Report Number
    3006179046-2021-00313
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Report Date
    June 16, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    PMA / PMN Number
    K171791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN MADE AVAILABLE TOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. IF ANY PERTINENT ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THE THE ROD BROKE JUST ABOVE THE DISTAL ANCHOR ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906056 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