BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 3831030 · Received May 23, 2014

    Report

    Report Number
    3006179046-2014-00012
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ELLIPSE TECHNOLOGIES, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DISTRIBUTOR ALLEGED THAT AFTER REVIEWING X-RAYS RESULTS, A PATIENT'S RIGHT ROD DID NOT DISTRACT AFTER THEIR LENGTHENING SESSION. THE PATIENT WAS IMPLANTED WITH DUAL MAGEC RODS OVER ONE (1) YEAR AGO. THE DEVICES ARE STILL IMPLANTED IN THE PATIENT. AT THIS TIME, THE SURGEON REPORTED THAT THE RIGHT MAGEC ROD WILL NOT BE REMOVED AS THE PATIENT'S CONDITION IS STABLE. NO NEGATIVE OUTCOMES HAVE BEEN REPORTED; THE PATIENT IS ASYMPTOMATIC AND IS DOING FINE. THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. A DHR REVIEW OF THE DEVICE 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 ALLEGED THAT AFTER REVIEWING X-RAYS RESULTS, A PATIENT'S RIGHT ROD DID NOT DISTRACT AFTER THEIR LENGTHENING SESSION. THE PATIENT HAS BEEN IMPLANTED WITH DUAL MAGEC RODS FOR OVER ONE YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307982 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM- MAGNETIC ACTUATION PGN ELLIPSE TECHNOLOGIES, INC. RA002-5555SL A120625-07

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other