BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 4183036 · Received October 17, 2014

    Report

    Report Number
    3006179046-2014-00027
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ELLIPSE TECHNOLOGIES, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REMOVED AND THE PATIENT WAS IMPLANTED WITH A NEW MAGEC ROD, WITHOUT INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND NO NEGATIVE OUTCOMES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS INITIALLY IMPLANTED WITH DUAL MAGEC RODS ON (B)(6) 2013. TO DATE, THE PATIENT IS DOING WELL AND IS ASYMPTOMATIC. THE SURGEON HAS NOT REMOVED THE DEVICE AT THIS TIME AS THE PATIENT'S CONDITION IS STABLE. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS AND THAT THE DEVICE WAS RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A REPRESENTATIVE REPORTED THAT DURING A PATIENT'S MAGEC ROD DISTRACTION SESSION, THE PATIENT'S LEFT MAGEC ROD APPEARED TO HAVE HAD SEPARATED AT THE DISTAL END, AFTER REVIEWING ULTRASOUND IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661906 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM- MAGNETIC ACTUATION PGN ELLIPSE TECHNOLOGIES, INC. RA002-5555SL A130222-03

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other