BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4WEB ANTERIOR TRUSS SYSTEM

    MDR report key: 10575406 · Received September 23, 2020

    Report

    Report Number
    3009189869-2020-00013
    Event Type
    Malfunction
    Date Received
    September 23, 2020
    Date of Event
    August 25, 2020
    Report Date
    September 23, 2020
    Manufacturer
    4WEB, INC.
    Product Code
    MAX
    UDI-DI
    00812998036202
    PMA / PMN Number
    K112316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSERTER WAS RETURNED TO 4WEB AND ANALYZED. THE BROKEN THREAD WAS CONFIRMED. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT . CAUSE OF THREAD BREAKAGE IS UNKNOWN. IT WAS REPORTED THAT AFTER THE PRODUCT WAS SHIPPED BY THE MANUFACTURER, THE INSERTER WAS MODIFIED PRIOR TO USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO 4WEB THAT THE TIP OF THE ALIF INSERTER BROKE WITHIN THE THREAD HOLE OF THE IMPLANT WHILE THE SURGEON WAS TRYING TO READJUST THE CAGE DURING SURGERY. SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE OF THE INSERTER FROM THE CAGE. NO PATIENT INJURY OR DEATH REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036343 4WEB ANTERIOR TRUSS SYSTEM INTERBODY FUSION DEVICE INSERTER MAX 4WEB, INC. ASTS-000001 A000AA012 00812998036202

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR