BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB LATERAL SPINE TRUSS SYSTEM

    MDR report key: 17794480 · Received September 21, 2023

    Report

    Report Number
    3009189869-2023-00010
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 21, 2023
    Manufacturer
    4WEB, INC.
    Product Code
    MAX
    PMA / PMN Number
    K153436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE SURGERY WAS COMPLETED SUCCESSFULLY, THE LATERAL IMPLANT REMAINS IMPLANTED IN THE PATIENT. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE SURGEON INDICATED THAT HE DID NOT BELIEVE THE DEVICE CAUSED THE ADVERSE EVENT. THE EVENT WAS REPORTED TO HAVE OCCURRED IN AUSTRALIA.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER THAT THE LATERAL IMPLANT ROTATED OBLIQUELY WHEN THE PATIENT WAS MOVED FROM A LATERAL POSITION TO A PRONE POSITION DURING AN O-ARM SPIN. THE IMPLANT USED REMAINED IN THE PATIENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. HOWEVER, TWO HOURS OF SURGICAL TIME WAS ADDED FOR THE SURGEON TO ATTEMPT TO REPOSITION THE CAGE POSTERIORLY. THE SURGERY WAS COMPLETED AS AN OPEN PROCEDURE INSTEAD OF PERCUTANEOUS, AS INITIALLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87867 4WEB LATERAL SPINE TRUSS SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX 4WEB, INC. LSTS-MD1210-55-SP D001R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other