BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 3760095 · Received April 18, 2014

    Report

    Report Number
    3006179046-2014-00009
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ELLIPSE TECHNOLOGIES, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS NOT AN UNUSUAL EVENT FOR GROWING ROD PATIENTS. THE MAGEC ROD WAS REMOVED ON (B)(6) 2014. NO NEGATIVE OUTCOMES HAVE BEEN REPORTED. 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.). 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.

    Description of Event or Problem · 1

    UPON REVIEWING X-RAY RESULTS, A DOCTOR ALLEGED THAT A PATIENT'S MAGEC ROD APPEARED TO BE BROKEN; THE PATIENT HAD BEEN IMPLANTED WITH THE MAGEC ROD FOR ALMOST TWO (2) YEARS PRIOR TO THE ALLEGED BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237637 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM- MAGNETIC ACTUATION PGN ELLIPSE TECHNOLOGIES, INC. RA002-5555SL 111115006

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| O