BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 3729040 · Received April 7, 2014

    Report

    Report Number
    3006179046-2014-00007
    Event Type
    Injury
    Date Received
    April 7, 2014
    Report Date
    March 5, 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

    THIS IS NOT AN UNUSUAL EVENT FOR GROWING ROD PATIENTS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 TO REPLACE THE EXISTING ROD; 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.). 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

    A DISTRIBUTOR REPORTED THAT A PATIENT'S MAGEC ROD BROKE. THE PATIENT HAD BEEN IMPLANTED WITH THE MAGEC ROD FOR OVER ONE (1) YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206860 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM- MAGNETIC ACTUATION PGN ELLIPSE TECHNOLOGIES, INC. RA002-4545SL 120409-003

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization| O