BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE

    MDR report key: 19129344 · Received April 17, 2024

    Report

    Report Number
    3009189869-2024-00007
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 17, 2024
    Manufacturer
    4WEB, INC.
    Product Code
    HWJ
    UDI-DI
    00812998043903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER YET. IT WAS REPORTED THAT THE PLACEMENT OF THE INTERBODY MADE ALL TRAJECTORIES CHALLENGING. THE PRODUCTION RECORDS WERE REVIEWED BASED ON THE PART AND LOT NUMBER INFORMATION PROVIDED. NO MANUFACTURING DEVIATIONS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE EXACT CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED. THE EVENT WAS REPORTED TO HAVE OCCURRED IN AUSTRALIA.

    Description of Event or Problem · 0

    THE TIP OF THE STRAIGHT PUNCH AWL USED IN SURGERY BROKE WHEN SURGEON REMOVED THE AWL FROM THE CAGE. TIP OF AWL REMAINS IN PATIENT WITHIN THE INTEGRATED 4WEB CAGE. NO INJURY TO PATIENT WAS REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539736 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE STRAIGHT PUNCH AWL HWJ 4WEB, INC. ASTS-SA-100006 30394 00812998043903

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown