BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4WEB ANTERIOR SPINE TRUSS SYSTEM

    MDR report key: 20163489 · Received September 6, 2024

    Report

    Report Number
    3009189869-2024-00016
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 6, 2024
    Manufacturer
    4WEB, INC.
    Product Code
    MAX
    UDI-DI
    00812998034024
    PMA / PMN Number
    K170851
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND THE TIP BREAK WAS CONFIRMED. THE PRODUCTION RECORDS WERE REVIEWED, NO MANUFACTURING DEVIATIONS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE EXACT CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER THAT THREADED PORTION OF AN ALIF INSERTER SHEARED OFF IN THE CAGE DURING IMPLANT IMPACTION/INSERTION. THE INSERTER TIP WAS LEFT IN CAGE, INSIDE THE PATIENT. NO INJURY TO PATIENT WAS REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343003 4WEB ANTERIOR SPINE TRUSS SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX 4WEB, INC. ASTS-000007 B8957 00812998034024

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female