BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT

    MDR report key: 21493000 · Received February 28, 2025

    Report

    Report Number
    3009189869-2025-00006
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    February 10, 2025
    Report Date
    February 28, 2025
    Manufacturer
    4WEB, INC.
    Product Code
    QNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 REPORTER DOES NOT BELIEVE THAT IT IS AN ISSUE WITH THE INITIAL TALUS 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 DEVELOPED ARTHRITIS OVER TIME AND WAS EXPERIENCING PAIN. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020. REVISION SURGERY WAS COMPLETED USING ANOTHER 4WEB CUSTOM MADE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809838 PHYSICIAN DESIGNED CUSTOM ORTHOPEDIC IMPLANT QNN 4WEB, INC. 072820.14A J195838

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention