BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB POSTERIOR SPINE TRUSS SYSTEM

    MDR report key: 10186639 · Received June 23, 2020

    Report

    Report Number
    3009189869-2020-00007
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    April 8, 2020
    Report Date
    June 23, 2020
    Manufacturer
    4WEB, INC.
    Product Code
    MAX
    UDI-DI
    00812998022519
    PMA / PMN Number
    K171351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION NOR WERE RADIOGRAPHS PROVIDED. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUE RELATED TO MANUFACTURING 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 · 1

    DURING THE SIX MONTHS FOLLOW-UP AFTER THE ORIGINAL SURGERY INVOLVING L5-S1, THE SURGEON IDENTIFIED THAT ONE OF THE THREE IMPLANTED CAGE HAD MIGRATED INTO THE CANAL. THE PATIENT ALSO REPORTED PAIN. THE SURGEON PERFORMED A REVISION SURGERY TO IMPACT THE CAGE DEEPER INTO THE DISC SPACE SINCE THE IMPLANT COULD NOT BE SAFELY REMOVED. IT IS UNKNOWN WHICH OF THE THREE IMPLANTED CAGES IS RELATED TO THE REPORTED INCIDENT. THEREFORE, ALL THREE DEVICES ARE BEING REPORTED (DEVICE 1 OF 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649895 4WEB POSTERIOR SPINE TRUSS SYSTEM INTERBODY FUSION DEVICE MAX 4WEB, INC. PSTS-SM0609-26-SP D001 00812998022519

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention