BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 4770300 · Received May 13, 2015

    Report

    Report Number
    3006179046-2015-00015
    Event Type
    Injury
    Date Received
    May 13, 2015
    Report Date
    April 13, 2015
    Manufacturer
    ELLIPSE TECHNOLOGIES, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAGEC ROD WAS REMOVED AND THE PATIENT WAS IMPLANTED WITH A NEW MAGEC ROD, WITHOUT INCIDENT. IT WAS REPORTED THAT THE PATIENT WAS "ACTIVELY CLIMBING/JUMPING" ON PLAYGROUND EQUIPMENT, WHICH MAY HAVE CONTRIBUTED TO THE ALLEGED INCIDENT. AN INITIAL VISUAL INSPECTION OF THE DEVICE REVEALED THAT THE ROD APPEARED TO HAVE HAD SEPARATED AT A SOLID SECTION OF THE END CAP PORTION. TO DATE, THE PATIENT IS DOING FINE AND CONTINUING THEIR TREATMENT WITH MAGEC; NO NEGATIVE OUTCOMES HAVE BEEN REPORTED. DHR REVIEW REVEALED THAT THE DEVICE MET ALL OF THE REQUIRED QUALITY INSPECTIONS AND WAS RELEASED WITHIN SPECIFICATIONS. THIS IS NOT AN UNUSUAL EVENT FOR GROWING ROD PATIENTS. 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.).

    Description of Event or Problem · 1

    A SURGEON ALLEGED THAT A PATIENT'S MAGEC ROD APPEARED TO HAVE HAD SEPARATED AT THE DISTAL PORTION OF THE ROD, WHERE THE DEVICE WAS CONTOURED AT THE TIME OF THE INITIAL IMPLANTATION. THE PATIENT WAS IMPLANTED WITH DUAL MAGEC RODS FOR APPROXIMATELY TEN (10) MONTHS PRIOR TO THE ALLEGED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313037 MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM-MAGNETIC ACTUATION PGN ELLIPSE TECHNOLOGIES, INC. MS1-45490S A140401-02-00-04U

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization