BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 3887391 · Received June 23, 2014

    Report

    Report Number
    3006179046-2014-00018
    Event Type
    Injury
    Date Received
    June 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    ELLIPSE TECHNOLOGIES, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAGEC ROD WAS REMOVED AND REPLACED WITH A NEW MAGEC ROD, WITHOUT INCIDENT. TO DATE, THE DEVICE INVOLVED IN THE ALLEGED INCIDENT HAS NOT BEEN RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS AND THAT THE DEVICE WAS RELEASED WITHIN SPECIFICATIONS. THE DEVICE INVOLVED IN THE ALLEGED INCIDENT IS A PRIOR VERSION OF THE DEVICE CLEARED UNDER K140178 AND IS NO LONGER COMMERCIALLY AVAILABLE IN THE US OR OUS. OUT OF AN ABUNDANCE OF CAUTION A REPORT IS BEING SUBMITTED WITH REGARD TO THE ALLEGED SERIOUS INJURY.

    Description of Event or Problem · 1

    A DISTRIBUTOR ALLEGED THAT AFTER A PATIENT'S MAGEC ROD DISTRACTION SESSION WAS PERFORMED ON (B)(6) 2014, THE DEVICE APPEARED TO RETRACT BY APPROXIMATELY 4MM. THE PATIENT HAD UNDERGONE APPROXIMATELY FIVE (5) DISTRACTION SESSIONS PRIOR TO ALLEGED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365049 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM- MAGNETIC ACTUATION PGN ELLIPSE TECHNOLOGIES, INC. RA002-5555SL 111215-010

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R