BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB LUMBAR SPINE TRUSS SYSTEM

    MDR report key: 19488807 · Received June 7, 2024

    Report

    Report Number
    3009189869-2024-00011
    Event Type
    Injury
    Date Received
    June 7, 2024
    Date of Event
    May 17, 2024
    Report Date
    June 7, 2024
    Manufacturer
    4WEB, INC.
    Product Code
    OVD
    PMA / PMN Number
    K203065
    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 TO THE MANUFACTURER. THE CAUSE OF THE MIGRATION COULD NOT BE ESTABLISHED WITH THE INFORMATION AVAILABLE TO THE MANUFACTURER. INFORMATION RECEIVED DID NOT INDICATE AN ISSUE WITH THE DEVICE(S) INVOLVED. THE CAGE REMAINS IMPLANTED IN THE PATIENT. THE SUPPLEMENTAL FIXATION WAS REMOVED AND REPLACED BY A NEW 4WEB SCREWS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO 4WEB THAT A REVISION SURGERY WAS REQUIRED AS 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE CAGE WAS REPORTED TO HAVE MIGRATED ANTERIORLY. PER INFORMATION RECEIVED, IT IS BELIEVED THAT THE PATIENT PRESENTED WITH PAIN ABOUT ONE AND A HALF MONTH POST INITIAL SURGERY. THE INITIAL SURGERY WAS COMPLETED USING 2 4WEB SCREWS AND PLATE AND WAS PERFORMED ON (B)(6) 2024. REPORT THREE OF THREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325192 4WEB LUMBAR SPINE TRUSS SYSTEM INTERVERTEBRAL FUSION DEVICE OVD 4WEB, INC. LSCR-5525-NS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention