BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXXT MATRIXX INTERBODY SYSTEM

    MDR report key: 8430343 · Received March 18, 2019

    Report

    Report Number
    3007922509-2019-00001
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    January 9, 2019
    Report Date
    March 6, 2019
    Manufacturer
    NEXXT SPINE LLC
    Product Code
    MQP
    UDI-DI
    00889929026229
    PMA / PMN Number
    K171140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF MANUFACTURING RECORDS SHOWS THE PRODUCT WAS RELEASED WITH NO ANOMALIES AND CONFORMING TO DESIGN SPECIFICATIONS. AS PART OF RISK MANAGEMENT, THE CONDITION IS ADDRESSED IN THE IFU AND SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2019 THAT A TLIF OBLIQUE IMPLANT FRACTURED DURING THE INSERT AND ROTATE TECHNIQUE. THE PROCEDURE INVOLVED THE IMPLANTATION OF TWO TLIF OBLIQUE CAGES. ONE WAS SUCCESSFUL. THE SURGEON POUNDED A SECOND 30DX10WX12H TLIF OBLIQUE IMPLANT INTO A 4MM DISC SPACE, INCREASING THE DISC SPACE TO 10MM TO ACCOMMODATE THE INTERBODY. WHEN ROTATING FROM 10MM TO 12MM ORIENTATION, THE INTERBODY BROKE. THE SURGEON USED EXCESSIVE FORCE TO ROTATE THE INTERBODY WHICH EXCEEDED THE DESIGN LIMITS FOR ROTATION. THE IMPLANT WAS INVESTIGATED TO BE SECURE, AND NO PIECES BROKE OFF OR FELL INTO THE WOUND, SO IT WAS LEFT IN PLACE TO PERFORM ITS INTENDED FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220935 NEXXT MATRIXX INTERBODY SYSTEM MATRIXX TLIF OBLIQUE MQP NEXXT SPINE LLC 54M-30-12-SP NS8633C 00889929026229

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention