BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 6110231 · Received November 17, 2016

    Report

    Report Number
    3006179046-2016-00039
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    January 6, 2020
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS IMPLANTED WITH DUAL MAGEC RODS (LOT# A140919-05-00; MANUFACTURE DATE 09/01/2014, EXPIRATION DATE 09/01/2016, AND LOT# A140812-01-00; MANUFACTURE DATE 08/01/2014, EXPIRATION DATE 08/01/2016), 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.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT WAS SENT TO UPDATE THE MFR REPORT NUMBER. SUPPLEMENTAL 3001679046-2016-00039-1 WAS SUBMITTED UNDER THE INCORRECT REPORT NUMBER.

    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 TWO (2) YEARS OF IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759808 MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM-MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. RA002-4545SL70, RA002-4545SLR70 A140919-05-00, A140812-01-00

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization