BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRIXX SYSTEM

    MDR report key: 8001622 · Received October 24, 2018

    Report

    Report Number
    3007922509-2018-00002
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    February 16, 2018
    Report Date
    June 27, 2018
    Manufacturer
    NEXXT SPINE LLC
    Product Code
    ODP
    PMA / PMN Number
    K171140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT MIGRATION. SURGEON USED IMPLANT OFF LABEL IN A PROCEDURE THAT CONSISTS OF PEDICLE SCREWS ON ONE SIDE AND A FACET SCREW ON THE CONTRA-LATERAL SIDE. THE PROCEDURE IS TISSUE SPARING FOR THE PATIENT BUT DOES NOT ALLOW BILATERAL COMPRESSION OF THE VERTEBRAL BODIES DOWN ONTO THE INTERBODY IMPLANT. HENCE, THE IMPLANT WAS IMPLANTED IN AN UNBOUND LOCATION AND SUBSEQUENTLY MIGRATED TO A NEW LOCATION. SURGEON CALLED TO ASK FOR ADVICE ON TWO PATIENTS WHEN DESCRIBING THE SCENARIO BUT DID NOT SHARE ANY PATIENT INFORMATION. TWO IDENTICAL MDR'S ARE BEING SUBMITTED TO ACCOUNT FOR EACH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843437 MATRIXX SYSTEM MATRIXX ODP NEXXT SPINE LLC 55M-22-09-SP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention