BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 11664872 · Received April 14, 2021

    Report

    Report Number
    3006179046-2021-00233
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    February 9, 2021
    Report Date
    April 23, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    UDI-DI
    00856719002114
    PMA / PMN Number
    K171791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4 PART NUMBER AND LOT NUMBER OF THE AFFECTED ROD ARE UNKNOWN, HOWEVER, THE FOLLOWING RODS WERE IMPLANTED IN THE PATIENT: RA002-5555SLR; LOT A130913-04 RA002-5555SL; LOT A130604-09

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    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 RELEVANT ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A ROD FRACTURED POST-OPERATIVELY. IT WAS REPORTED THAT A REVISION PROCEDURE IS PLANNED FOR A LATER DATE. NO PATIENT ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564069 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM - MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. UNKNOWN UNKNOWN 00856719002114

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR