BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM

    MDR report key: 5820403 · Received July 25, 2016

    Report

    Report Number
    3006179046-2016-00024
    Event Type
    Injury
    Date Received
    July 25, 2016
    Report Date
    June 28, 2016
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    PGN
    PMA / PMN Number
    K140178
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS IMPLANTED WITH DUAL MAGEC RODS (MS1-5590S, LOT# A120521-09-10-01U AND MS1-5590R, LOT# A140807-04-00-01U) ON (B)(6) 2014, AND IT WAS ALLEGED THAT DURING THE FIRST TWO (2) DISTRACTION SESSIONS, THE RODS APPEARED TO NOT BE DISTRACTING; HOWEVER, BOTH RODS DISTRACTED AND FUNCTIONED AS EXPECTED WHEN TESTED PRIOR TO IMPLANTATION. BOTH RODS WERE REMOVED ON (B)(6) 2016; THE PATIENT UNDERWENT A FINAL FUSION PROCEDURE, AND WAS NOT IMPLANTED WITH NEW RODS. 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 DEVICE WAS RELEASED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED THAT A SURGEON ALLEGED THAT DURING THE FIRST TWO (2) DISTRACTION SESSIONS, A PATIENT'S DUAL MAGEC RODS APPEARED TO NOT BE DISTRACTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473678 MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM GROWING ROD SYSTEM-MAGNETIC ACTUATION PGN NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MS1-5590S, MS1-5590R

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization