BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIOFIBER HAMMERTOE FIXATION SYSTEM

    MDR report key: 23346201 · Received October 21, 2025

    Report

    Report Number
    3014554088-2025-00005
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    November 1, 2024
    Report Date
    October 21, 2025
    Manufacturer
    OSSIO LTD.
    Product Code
    HTY
    UDI-DI
    07290017630076
    PMA / PMN Number
    K190652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY WAS NOTIFIED OF A REVISION SURGERY. AN INVESTIGATION WAS PERFORMED BASED ON THE INFORMATION PROVIDED BY THE SURGEON AND PRODUCTION RECORDS. SURGEON REPORTED THAT A PATIENT WHO HAS RHEUMATOID ARTHRITIS (PRE-EXISTING AUTO-IMMUNE DISORDER), HAD WHAT APPEARS AS A LOCAL INFLAMMATORY REACTION, WHICH LED TO REPLACEMENT OF THE IMPLANT WITH A K-WIRE. PATIENT WAS REPORTED TO HAVE HEALED FOLLOWING THE REVISION. THE DEVICE COULD NOT BE EXAMINED AS IT WAS NOT PROVIDED. NO IMAGING OR TEST RESULTS WERE PROVIDED. THERE IS NO INDICATION OF A DESIGN, MANUFACTURING OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. IMPLANTATION IN PATIENTS WITH AUTOIMMUNE DISORDERS IS NOT SPECIFICALLY CONTRAINDICATED, NEVERTHELESS, COMPANY CANNOT RULE OUT IN ADVANCE AN INFLAMMATORY REACTION IN FACE OF AUTOIMMUNE CONDITIONS. THE IMPLANT INSTRUCTIONS FOR USE RECOMMENDS PRECAUTION AND EVALUATION OF EACH SITUATION INDIVIDUALLY BASED ON THE PATIENT'S HISTORY, CLINICAL PRESENTATION, AND CONCOMITANT MEDICATIONS USE. IT ALSO LISTS AN INFLAMMATORY OR ALLERGIC REACTION AS A POTENTIAL ADVERSE EFFECT TO IMPLANTATION OF FOREIGN MATERIAL. INFLAMMATORY REACTION CAN BE THE RESULT OF NUMEROUS REASONS AND IS A KNOWN INHERENT RISK OF THE DEVICE AND SURGICAL PROCEDURE. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE IS LIKELY THE OUTCOME OF THE PATIENT EXPERIENCING A LOCAL REACTION DUE TO PRE-EXISTING CONDITION, THOUGH OTHER CAUSES COULD NOT BE RULED OUT. BECAUSE THE COMPANY CANNOT RULE OUT THE POSSIBLE CONTRIBUTION OF THE DEVICE TO THE EVENT, OUT OF AN ABUNDANCE OF CAUTION, THIS EVENT IS BEING REPORTED. COMPANY CONTINUES TO MONITOR THESE EVENTS AS PART OF POST MARKET ACTIVITIES. ADDITIONAL REPORT FROM THE INITIAL IMPORTER RELATING TO THIS EVENT IS: #3014323288-2025-00005.

    Description of Event or Problem · 0

    REVISION PROCEDURE ABOUT 1 MONTH FOLLOWING HAMMERTOE FIXATION SURGERY DUE TO LOCAL INFLAMMATORY REACTION IN A PATIENT WITH RHEUMATOID ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284584 OSSIOFIBER HAMMERTOE FIXATION SYSTEM PIN, FIXATION, SMOOTH HTY OSSIO LTD. OF04885 07290017630076

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention