BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4WEB OSTEOTOMY TRUSS SYSTEM

    MDR report key: 9419093 · Received December 5, 2019

    Report

    Report Number
    3009189869-2019-00014
    Event Type
    Injury
    Date Received
    December 5, 2019
    Date of Event
    November 7, 2019
    Report Date
    December 5, 2019
    Manufacturer
    4WEB, INC.
    Product Code
    HRS
    UDI-DI
    00812998024773
    PMA / PMN Number
    K172294
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO RADIOGRAPHS WERE PROVIDED. THERE WAS NO INFORMATION AVAILABLE ON WHETHER THE PATIENT WAS COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS. REVIEW OF PRODUCTION RECORDS DID NOT INDICATE ANY ISSUES RELATED TO MANUFACTURING THAT MAY HAVE CONTRIBUTED TO THE EVENT. INFORMATION RECEIVED INDICATED THAT SUPPLEMENTAL FIXATION WAS NOT USED DURING THE INITIAL SURGERY AS REQUIRED BY 4WEB MEDICAL OSTEOTOMY WEDGE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    APPROXIMATELY TEN MONTHS FOLLOWING THE INITIAL SURGERY USING A 4WEB OSTEOTOMY WEDGE, THE IMPLANT STARTED TO PROTRUDE DUE TO NON-UNION. REVISION SURGERY WAS PERFORMED IN WHICH THE 4WEB OSTEOTOMY WEDGE WAS EXPLANTED AND REPLACED WITH A PLATE AND TIBIAL AUTOGRAFT. THE REVISION WAS COMPLETED SUCCESSFULLY AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214728 4WEB OSTEOTOMY TRUSS SYSTEM OSTEOTOMY WEDGE HRS 4WEB, INC. EOTS-LG2206 00812998024773

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention