BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB CERVICAL SPINE TRUSS SYSTEM - STANDALONE

    MDR report key: 21225019 · Received January 23, 2025

    Report

    Report Number
    3009189869-2025-00004
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    December 26, 2024
    Report Date
    January 23, 2025
    Manufacturer
    4WEB, INC.
    Product Code
    OVE
    UDI-DI
    00812998039371
    PMA / PMN Number
    K190870
    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. THE CAUSE OF THE EVENT COULD NOT BE ESTABLISHED WITH THE INFORMATION AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED TO 4WEB MEDICAL THAT A 4WEB CAGE, PLATE AND A PAIR OF SCREWS WERE EXPLANTED DUE TO ADJACENT LEVEL DISEASE. THE REVISION WAS PERFORMED ABOUT FIVE MONTHS POST INITIAL SURGERY, ON (B)(6)2024. NO ISSUES OR COMPLICATIONS REPORTED DURING THE REVISION SURGERY. TWO SET OF SCREWS WERE USED DURING THE SURGERY. IT IS UNKNOWN WHICH PAIR IS RELATED TO THE REPORTED INCIDENT. THEREFORE, BOTH DEVICES ARE BEING REPORTED. (DEVICE 4 OF 4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860000 4WEB CERVICAL SPINE TRUSS SYSTEM - STANDALONE INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE 4WEB, INC. CSCR-3514-SD-SP R005 00812998039371

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention