BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 5880164 · Received August 16, 2016

    Report

    Report Number
    3006179046-2016-00028
    Event Type
    Injury
    Date Received
    August 16, 2016
    Report Date
    July 21, 2016
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS IMPLANTED WITH DUAL MAGEC RODS (LOT# A150128-11; MANUFACTURE DATE 01/02/2015, EXPIRATION DATE 01/02/2017, AND LOT# A150319-22; MANUFACTURE DATE 03/01/2015, EXPIRATION DATE 03/01/2017), AND IT WAS ALLEGED THAT THE RODS APPEARED 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 THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS, AND THE DEVICES WERE RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT A SURGEON ALLEGED THAT A PATIENT'S DUAL MAGEC RODS APPEARED TO NOT BE DISTRACTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532570 MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM-MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MS1-4590R, MS1-4590S A150128-11, A150319-22

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization