BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE

    MDR report key: 20025630 · Received August 22, 2024

    Report

    Report Number
    3009189869-2024-00014
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 31, 2024
    Report Date
    August 20, 2024
    Manufacturer
    4WEB, INC.
    Product Code
    OVD
    UDI-DI
    00812998043989
    PMA / PMN Number
    K200002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED TO THE MANUFACTURER AS IT WAS REPORTED TO BE DISCARDED. THE PRODUCTION RECORDS WERE REVIEWED BASED ON THE PART AND LOT NUMBER INFORMATION PROVIDED. NO MANUFACTURING DEVIATIONS WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE EXACT CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED. THE EVENT WAS REPORTED TO HAVE OCCURRED IN ECUADOR.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER THAT SURGEON HAD ISSUES RE-ENGAGING AN ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE FREEHAND INSERTER INTO THE CAGE TO REPOSITION IT. THIS LED TO OVER SIXTY MINUTES OF ADDITIONAL SURGICAL TIME. NO INJURY TO PATIENT WAS REPORTED. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300547 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR, REUSABLE OVD 4WEB, INC. ASTS-SA-100014 30402-R 00812998043989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other