BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIXX SYSTEM

    MDR report key: 8506560 · Received April 11, 2019

    Report

    Report Number
    3007922509-2019-00002
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    January 23, 2019
    Report Date
    April 9, 2019
    Manufacturer
    NEXXT SPINE LLC
    Product Code
    MQP
    PMA / PMN Number
    K171140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT MIGRATION. MATRIXX TLIF IMPLANT MIGRATED AS NOTICED IN FOLLOW-UP PATIENT VISITS. WHEN SURGEON PUT THE IMPLANT IN ORIGINALLY, IT WASN'T FULLY TURNED INTO POSITION AS DESIRED, BUT SURGEON MADE A JUDGEMENT CALL TO LEAVE THE IMPLANT IN PLACE GIVEN THE IMPLANT'S ANTI-MIGRATION CAPABILITIES IN ORDER TO AVOID POSSIBLE NERVE DAMAGE BY FURTHER IMPLANT POSITIONING. THIS SUB-OPTIMAL POSITIONING RESULTED IN THE IMPLANT IRRITATING A NERVE ROOT, AND A REVISION SURGERY WAS THUS SCHEDULED 6 MONTHS AFTER THE ORIGINAL IMPLANTATION. THERE WAS SIGNIFICANT BONE GROWTH ON THE IMPLANT, BUT THE SURGEON WAS ABLE TO KNOCK IT OUT OF POSITION TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300004 MATRIXX SYSTEM MATRIXX MQP NEXXT SPINE LLC 57M-31L-09-SP NS8381C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention