BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB POSTERIOR SPINE TRUSS SYSTEM

    MDR report key: 20347906 · Received October 1, 2024

    Report

    Report Number
    3009189869-2024-00017
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    September 3, 2024
    Report Date
    October 1, 2024
    Manufacturer
    4WEB, INC.
    Product Code
    MAX
    UDI-DI
    00812998022984
    PMA / PMN Number
    K143258
    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 FOR EVALUATION NOR RADIOGRAPHS PROVIDED. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUE RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. PSEUDOARTHROSIS WAS REPORTED AND PER INFORMATION AVAILABLE, THE PATIENT HAD OTHER COMORBIDITIES. 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 REVISION SURGERY WAS PERFORMED TO REMOVE A 4WEB POSTERIOR CAGE THAT MIGRATED. THE REVISION SURGERY WAS PERFORMED ABOUT THREE AND A HALF MONTHS POST INITIAL SURGERY. THE 4WEB IMPLANT WAS REMOVED AND REPLACED WITH AN EXPANDABLE CAGE FROM A DIFFERENT VENDOR. NO ISSUES NOTED DURING THE INITIAL OR REVISION SURGERY. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44296 4WEB POSTERIOR SPINE TRUSS SYSTEM INTERBODY FUSION DEVICE MAX 4WEB, INC. PSTS-MD0612-26-SP D004 00812998022984

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention