BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 3831585 · Received May 25, 2014

    Report

    Report Number
    3006179046-2014-00016
    Event Type
    Injury
    Date Received
    May 25, 2014
    Report Date
    April 25, 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

    ON (B)(4) 2014 A DISTRIBUTOR REPORTED THAT A PATIENT EXPERIENCED AN INFECTION AFTER BEING IMPLANTED WITH DUAL MAGEC RODS. THE PATIENT WAS PRESENTED WITH FEVER, PAIN, AND DISCHARGE FROM THE INFECTED AREA (SURFACE OF SKIN). DUAL MAGEC RODS WERE IMPLANTED IN THE PATIENT ON (B)(6) 2010. UPON CLARIFICATION FROM THE DISTRIBUTOR, IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AFTER EACH LENGTHENING SESSION; THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE INFECTION SITE (SURFACE OF THE SKIN) WAS DEBRIDED EACH TIME. THE SURGEON REMOVED THE PATIENT'S MAGEC RODS ON (B)(6) 2014 AND TREATED THE INFECTION WITH ANTIBIOTICS. NO LOT NUMBERS WERE PROVIDED; AN EVALUATION OF THE RETURNED RODS IS ANTICIPATED, BUT HAS NOT YET BEGUN. THE DEVICES INVOLVED IN THE ALLEGED INCIDENT ARE PRIOR VERSIONS OF THE DEVICE CLEARED UNDER K140178 AND ARE NO LONGER COMMERCIALLY AVAILABLE IN THE US OR OUS. OUT OF AN ABUNDANCE OF CAUTION A REPORT IS BEING SUBMITTED WITH REGARD TO THE ALLEGED SERIOUS INJURY.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT A PATIENT DEVELOPED AN INFECTION AFTER BEING IMPLANTED WITH DUAL MAGEC RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309705 MAGEC SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM- MAGNETIC ACTUATION PGN ELLIPSE TECHNOLOGIES, INC. RA002-5555SL AND RA002-5555SLR

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization| O