BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 5283270 · Received December 9, 2015

    Report

    Report Number
    3006179046-2015-00044
    Event Type
    Injury
    Date Received
    December 9, 2015
    Report Date
    November 9, 2015
    Manufacturer
    ELLIPSE TECHNOLOGIES, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S MAGEC ROD WAS REMOVED AND THE PATIENT WAS IMPLANTED WITH A NEW MAGEC ROD, WITHOUT INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND CONTINUING THEIR TREATMENT WITH MAGEC; NO NEGATIVE OUTCOMES WERE REPORTED. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS AND THAT THE DEVICE 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 DISTRIBUTOR ALLEGED THAT A PATIENT'S MAGEC ROD APPEARED TO HAVE HAD SEPARATED AT A SOLID SECTION AFTER ONE (1) YEAR OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811511 MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM-MAGNETIC ACTUATION PGN ELLIPSE TECHNOLOGIES, INC. RA002-4545SL A140122-01

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization