BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 12584695 · Received October 6, 2021

    Report

    Report Number
    3006179046-2021-00479
    Event Type
    Injury
    Date Received
    October 6, 2021
    Report Date
    November 15, 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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED AND IS PENDING EVALUATION. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT THE ROD FAILED TO LENGTHEN. NO PATIENT ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480409 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM - MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MS1-4590S 0070110AAA 00812258026295

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Hospitalization