BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 6424430 · Received March 22, 2017

    Report

    Report Number
    3006179046-2017-00006
    Event Type
    Injury
    Date Received
    March 22, 2017
    Report Date
    January 8, 2017
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RODS (LOT# A121017-01, MANUFACTURE DATE 10/01/2012, EXPIRATION DATE 10/01/2014 AND LOT# A130116-02, MANUFACTURE DATE 01/02/2013, EXPIRATION DATE 01/02/2015) WERE REMOVED AND THE PATIENT WAS IMPLANTED WITH NEW DUAL MAGEC RODS WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE AND NO NEGATIVE OUTCOMES HAVE BEEN REPORTED. TO DATE, THE DEVICES HAVE NOT BEEN RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. A DHR REVIEW REVEALED THAT THE DEVICES MET ALL OF THE REQUIRED QUALITY INSPECTIONS AND WERE RELEASED WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THREE (3) YEARS OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206568 MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM-MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. RA002-4545SLR, RA002-4545SL A121017-01, A130116-02

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization