BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

    MDR report key: 21294156 · Received February 3, 2025

    Report

    Report Number
    3009189869-2025-00005
    Event Type
    Injury
    Date Received
    February 3, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 3, 2025
    Manufacturer
    4WEB, INC.
    Product Code
    QNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT OF THIS FILING WAS UNIQUELY DESIGNED FOR THIS PATIENT'S SPECIFIC PATHOLOGY BY THE PRESCRIBING PHYSICIAN. THE SURGEON DOES NOT BELIEVE IT IS AN ISSUE WITH THE IMPLANT; THE PATIENT WAS REPORTED TO HAVE DEVELOPED ARTHRITIS. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. NO PRODUCT WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    4WEB WAS NOTIFIED THAT A CUSTOM MADE 4WEB TOTAL TALUS DEVICE WAS EXPLANTED ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAINFUL SUB-TALAR JOINT. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2019. REVISION SURGERY WAS COMPLETED USING ANOTHER 4WEB CUSTOM MADE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179374 PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT QNN 4WEB, INC. 080919.02B J177442

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention