BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB LATERAL SPINE TRUSS SYSTEM

    MDR report key: 23058134 · Received September 15, 2025

    Report

    Report Number
    3009189869-2025-00012
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 15, 2025
    Manufacturer
    4WEB, INC.
    Product Code
    HWT
    PMA / PMN Number
    K172392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SIZERS WERE RETURNED TO 4WEB POST-SURGERY FOR INVESTIGATION. NO EVIDENCE OF BIO-BURDEN WAS OBSERVED. PRODUCTION RECORDS FOR ALL SIZERS INVOLVED WERE REVIEWED, AND NO MANUFACTURING DEVIATIONS WERE FOUND THAT COULD HAVE CONTRIBUTED TO THE INCIDENT. ADDITIONALLY, THERE IS NO TREND OF COMPLAINTS FROM THE FIELD REGARDING THE PRESENCE OF BIO-BURDEN FOLLOWING SPD PROCESSING. THERE IS NOT ENOUGH EVIDENCE TO CONCLUDE THAT THE 210-MINUTE SURGICAL DELAY IS ATTRIBUTABLE TO THE 4WEB SIZERS OR THEIR DESIGN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO 4WEB THAT BIO-BURDEN WAS OBSERVED ON ONE OF THE 4WEB LATERAL SIZERS DURING SURGERY. AT THE SURGEON'S REQUEST, THE INSTRUMENT TRAY WAS SENT FOR RE-STERILIZATION WHILE THE PATIENT REMAINED OPEN. THE RE-STERILIZATION PROCESS TOOK APPROXIMATELY 3.5 HOURS (210 MINUTES). THE PROCEDURE WAS SUBSEQUENTLY COMPLETED SUCCESSFULLY, AND NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681444 4WEB LATERAL SPINE TRUSS SYSTEM SURGICAL IMPLANT TEMPLATE, REUSABLE HWT 4WEB, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other