BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 6071523 · Received November 1, 2016

    Report

    Report Number
    3006179046-2016-00038
    Event Type
    Injury
    Date Received
    November 1, 2016
    Report Date
    October 3, 2016
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS IMPLANTED WITH DUAL MAGEC RODS (LOT# A131126-03; MANUFACTURE DATE 11/01/2013, EXPIRATION DATE 11/01/2015, AND LOT# A131004-01; MANUFACTURE DATE 10/01/2013, EXPIRATION DATE 10/01/2015), AND IT WAS ALLEGED THAT THE RODS APPEAR TO NOT BE DISTRACTING. THE RODS WERE REMOVED ON (B)(6) 2016, AND THE PATIENT WAS IMPLANTED WITH NEW DUAL MAGEC RODS WITHOUT INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND NO NEGATIVE OUTCOMES HAVE BEEN REPORTED. A DHR REVIEW REVEALED THAT THE RODS MET ALL OF THE REQUIRED QUALITY INSPECTIONS AND WERE RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT A SURGEON ALLEGED THAT A PATIENT'S DUAL MAGEC RODS APPEAR TO NOT BE DISTRACTING AFTER OVER TWO (2) YEARS OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721719 MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM-MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. RA002-4545SL, RA002-4545SLR A131126-03, A131004-01

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization