BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIOFIBER COMPRESSION STAPLE SYSTEM

    MDR report key: 23932445 · Received December 31, 2025

    Report

    Report Number
    3014554088-2025-00009
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    November 27, 2025
    Report Date
    January 21, 2026
    Manufacturer
    OSSIO LTD.
    Product Code
    OJH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON ADDITIONAL INFORMATION PROVIDED TO THE COMPANY, THE POSSIBLE CONTRIBUTION OF THE REPORTED DEVICE TO THE EVENT CAN BE RULED OUT.

    Additional Manufacturer Narrative · 0

    COMPANY WAS NOTIFIED OF A STAPLE REMOVAL SURGERY FOLLOWING A WEDGE LENGTHENING OSTEOTOMY IN THE ANKLE (WEDGE IMPLANT WAS FROM A DIFFERENT MANUFACTURER). NO IMAGING FROM THE ORIGINAL SURGERY WAS PROVIDED. AN MRI CROSS SECTION IMAGE PRE-REMOVAL WAS PROVIDED, AS WELL AS PHOTOS FROM THE REMOVAL PROCEDURE. NO ADDITIONAL INFORMATION WAS SHARED WITH THE COMPANY. THE REMOVED IMPLANT WAS NOT PROVIDED AND COULD NOT BE DEFINITIVELY IDENTIFIED BY THE PHOTOS. AN INVESTIGATION WAS CONDUCTED. BASED ON THE LIMITED INFORMATION AVAILABLE AND AS MORE THAN ONE IMPLANT FROM DIFFERENT MANUFACTURERS WERE IMPLANTED, THE ROOT CAUSE OF THE SWELLING WHICH LED TO THE REMOVAL SURGERY COULD NOT BE DETERMINED. LOCAL SWELLING AND ADDITIONAL REMOVAL SURGERY CAN BE THE RESULT OF VARIOUS REASONS AND ARE KNOWN INHERENT RISKS OF THE DEVICE USE AND SURGICAL PROCEDURE. AS A REMOVAL SURGERY WAS PERFORMED AND 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: #3014323288-2025-00009.

    Description of Event or Problem · 0

    COMPANY WAS NOTIFIED THAT THE INITIALLY UN-IDENTIFIED REMOVED IMPLANT WAS IDENTIFIED AS A WEDGE IMPLANT MANUFACTURED BY A DIFFERENT COMPANY. THUS, THE EVENT IS DETERMINED AS NOT RELATED TO THE INITIALLY REPORTED DEVICE.

    Description of Event or Problem · 0

    IMPLANT REMOVAL SURGERY FROM THE ANKLE DUE TO LOCAL SWELLING, APPROX.1.5Y FOLLOWING IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245886 OSSIOFIBER COMPRESSION STAPLE SYSTEM ORTHOPEDIC TRAY OJH OSSIO LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention WEDGE IMPLANT (UNKNOWN MANUFACTURER).