BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB CERVICAL SPINE TRUSS SYSTEM

    MDR report key: 24438667 · Received February 24, 2026

    Report

    Report Number
    3009189869-2026-00004
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 24, 2026
    Manufacturer
    4WEB, INC.
    Product Code
    ODP
    UDI-DI
    00812998039401
    PMA / PMN Number
    K221266
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED. PRODUCTION RECORDS OF ALL THE DEVICES INVOLVED IN THE INITIAL PROCEDURE WERE REVIEWED, NO ISSUES RELATED TO MANUFACTURING WERE NOTED THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE THAT THE 4WEB DEVICES CONTRIBUTED TO THE REVISION SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO 4WEB MEDICAL THAT A 4WEB CERVICAL CAGE, PLATE, AND SCREWS WERE EXPLANTED FOLLOWING A FALL THAT DAMAGED THE CONSTRUCT. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, LESS THAN A MONTH AFTER THE INITIAL SURGERY. NO ISSUES OR COMPLICATIONS REPORTED DURING THE REVISION PROCEDURE. DEVICE 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498504 4WEB CERVICAL SPINE TRUSS SYSTEM INTERBODY FUSION DEVICE ODP 4WEB, INC. CSCR-3816-SD-SP D002R 00812998039401

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown Other