BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIOFIBER CANNULATED TRIMMABLE FIXATION NAIL SYSTEM

    MDR report key: 23677012 · Received November 30, 2025

    Report

    Report Number
    3014554088-2025-00006
    Event Type
    Injury
    Date Received
    November 30, 2025
    Date of Event
    October 26, 2025
    Report Date
    November 30, 2025
    Manufacturer
    OSSIO LTD.
    Product Code
    OJH
    UDI-DI
    07290017630137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY WAS NOTIFIED OF REMOVAL PROCEDURE. ORIGINAL SURGERY INCLUDED 3 IMPLANTS IN THE 2ND,3RD AND 4TH TOES. THE IMPLANT FROM THE 2ND TOE WAS REMOVED IN OFFICE 2 MONTHS FOLLOWING IMPLANTATION, THE OTHERS WERE REMOVED ABOUT 2 WEEKS AFTER, IN THE OR. A PRODUCT INVESTIGATION WAS PERFORMED FOR ALL 3 DEVICES IMPLANTED. NO IMAGING WAS PROVIDED. NO REPORT OF TRAUMA. EVENT OCCURRED ABOUT THE TIME THE PATIENT WAS BACK TO NORMAL ACTIVITY LEVEL. NON-COMPLIANCE WAS NOT SUSPECTED. BASED ON INTERNAL ANALYSIS OF RECORDS AND PROCEDURES, THERE IS NO INDICATION OF A DESIGN, MANUFACTURING OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE INVESTIGATION, INCLUDING THE SURGEON'S FEEDBACK, CONCLUDED THAT THIS EVENT WAS LIKELY THE OUTCOME OF AN INAPPROPRIATE IMPLANT SIZE SELECTION, USING AN IMPLANT TOO SMALL FOR THE PATIENT BONE ANATOMY, WHICH RESULTED IN AN UNSTABLE IMPLANTATION SITE. SWELLING WAS ATTRIBUTED TO UNSTABLE FIXATION OF THE SURGICAL SITE. THE INSTRUCTIONS FOR USE INCLUDE PRECAUTIONS AND RECOMMENDATIONS FOR THE SELECTION OF APPROPRIATE SURGICAL TECHNIQUE, IMPLANT SIZE, CONFIGURATION, AND SURGICAL SITE PREPARATION. UNSTABLE FIXATION IS A KNOWN INHERENT RISK OF THE DEVICE AND SURGICAL PROCEDURE. ALTHOUGH THE COMPANY DOES NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, AS AN IMPLANT REMOVAL SURGERY WAS PERFORMED, THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. COMPANY CONTINUES TO MONITOR THESE EVENTS AS PART OF POST MARKET ACTIVITIES. ADDITIONAL REPORTS RELATING TO THIS EVENT ARE: # 3014554088-2025-00007/8, #3014323288-2025-00006/7/8.

    Description of Event or Problem · 0

    IMPLANT REMOVAL DUE TO LOCAL TOE SWELLING 2 MONTHS FOLLOWING A HAMMERTOE CORRECTION PROCEDURE. CASE RESOLVED WITH NO ADDITIONAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2120385 OSSIOFIBER CANNULATED TRIMMABLE FIXATION NAIL SYSTEM ORTHOPEDIC TRAY OJH OSSIO LTD. OF2053050S OF04835 07290017630137

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention OSSIOFIBER CANNULATED TRIMMABLE FIXATION NAIL SYS.| OSSIOFIBER CANNULATED TRIMMABLE FIXATION NAIL SYS.