BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HONOUR SPACER SYSTEM

    MDR report key: 8002286 · Received October 24, 2018

    Report

    Report Number
    3007922509-2018-00005
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    October 3, 2017
    Report Date
    June 27, 2018
    Manufacturer
    NEXXT SPINE LLC
    Product Code
    MAX
    UDI-DI
    00889929001936
    PMA / PMN Number
    K120345
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PEEK IMPLANT OF HEIGHT 10MM MIGRATED AS NOTICED IN AN X-RAY IN 2 WEEK POST-OP FOLLOW UP VISIT. SURGEON PERFORMED A REVISION SURGERY TO REPLACE THE 10MM IMPLANT WITH AN 11MM IMPLANT AS A BETTER FIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843694 HONOUR SPACER SYSTEM HONOUR SPACER SYSTEM MAX NEXXT SPINE LLC 21-229-10 00889929001936

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention