BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 3825850 · Received May 21, 2014

    Report

    Report Number
    3006179046-2014-00015
    Event Type
    Injury
    Date Received
    May 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ELLIPSE TECHNOLOGIES, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DISTRIBUTOR REPORTED THAT A PATIENT'S MAGEC ROD BROKE. THE PATIENT WAS IMPLANTED WITH DUAL MAGEC RODS IN 2012. THE EXACT DATE OF IMPLANTATION WAS IS UNKNOWN; THIS IS NOT AN UNUSUAL EVENT FOR GROWING ROD PATIENTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 TO REMOVE THE ALLEGED BROKEN. THE PATIENT WAS IMPLANTED WITH A NEW MAGEC ROD, WITHOUT INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND NO NEGATIVE OUTCOMES HAVE BEEN NOTED. IN THE LITERATURE, GROWING RODS HAVE BEEN REPORTED TO BREAK IN APPROXIMATELY 25% OF CASES (BESS S, ET.AL., "COMPLICATIONS OF GROWING-ROD TREATMENT FOR EARLY ONSET SCOLIOSIS: ANALYSIS OF ONE HUNDRED AND FORTY PATIENTS", J BONE JOINT SURG AM. 2010; 92: 1-11.). AN EVALUATION OF THE RETURNED DEVICE IS IN PROCESS. 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 REPORTED THAT A PATIENT'S MAGEC ROD BROKE. THE PATIENT WAS IMPLANTED WITH DUAL MAGEC RODS IN 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303086 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM- MAGNETIC ACTUATION PGN ELLIPSE TECHNOLOGIES, INC. RA002-4545SL 110124-004

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| O