BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDFUSE

    MDR report key: 8622107 · Received May 17, 2019

    Report

    Report Number
    3005977257-2019-00004
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    January 25, 2018
    Report Date
    May 17, 2019
    Manufacturer
    SPINEFRONTIER INC
    Product Code
    MNH
    UDI-DI
    00190361010586
    PMA / PMN Number
    K123164
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS ESTABLISHES THAT THIS LOT OF SET SCREW WAS MANUFACTURED, INSPECTED AND RELEASED TO DISTRIBUTION WITH OUT ANY NONCONFORMANCES. SPINEFRONTIER INVESTIGATION INTO THIS MATTER ESTABLISHES THE ROOT CAUSE OF THE OCCURRENCE WAS DIRECTLY RELATED TO ALIGNING THE SET SCREW. THE SURGICAL TECHNIQUE INCLUDES ADEQUATE INSTRUCTIONS ON SET SCREW ALIGNMENT AND ACTIONS TO TAKE IF THE SET SCREWS DOES NOT ADVANCE WITH MINIMAL RESISTANCE. THE SURGEON PLACING THE DEVICE HAS SEVERAL YEARS OF EXPERIENCE IMPLANTING THIS DEVICE AND HAS COMPLETED NUMEROUS SUCCESSFUL SURGERIES WITHOUT COMPLICATIONS. FACTORS RELATING TO PATIENT ANATOMY MAY HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE. SPINEFROTIER IS CONSIDERING THIS INCIDENT CLOSED WITHOUT THE NEED FOR ANY ADDITIONAL ACTIONS.

    Description of Event or Problem · 1

    SPINEFRONTIER SALES REPRESENTATIVE REPORTED THAT THE SURGEON ENCOUNTERED DIFICULTY ADVANCING THE SET SCREW INTO THE TULIP DURING INITIAL PLACEMENT. THE SET SCREW GOT CROSS THREADED DURING THE PROCESS AND HAD TO BE REPLACED. THIS WAS THE FIRST OF TWO SET SCREW CROSS THREADING OCCURRENCE DURING THIS CASE. THE SECOND OCCURRENCE WAS REPORTED UNDER MDR 3005977257-2019-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414539 PEDFUSE PEDFUSE MNH SPINEFRONTIER INC 01-80101 DF21 00190361010586

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention