BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIXX SYSTEM

    MDR report key: 8506611 · Received April 11, 2019

    Report

    Report Number
    3007922509-2019-00003
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    February 5, 2019
    Manufacturer
    NEXXT SPINE LLC
    Product Code
    MAX
    PMA / PMN Number
    K171140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE MIGRATION. PATIENT END-PLATE ANATOMY LED TO SUB-OPTIMAL TLIF OBLIQUE IMPLANT POSITIONING IN INITIAL SURGERY. IN THE FOLLOWING WEEKS, IT WAS DISCOVERED THAT IMPLANT MIGRATED/BACKED-OUT, SO A SECOND SURGERY WAS COMPLETED TO RE-POSITION THE IMPLANT. THE IMPLANT WAS SUCCESSFULLY REPOSITIONED IN THE SECONDARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297888 MATRIXX SYSTEM MATRIXX TLIF OBLIQUE MAX NEXXT SPINE LLC 54M-26-11-SP NS7765A OR NS9382C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention