BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIOFIBER THREADED TRIMMABLE FIXATION NAIL SYSTEM

    MDR report key: 23308031 · Received October 16, 2025

    Report

    Report Number
    3014554088-2025-00004
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    August 16, 2025
    Report Date
    October 16, 2025
    Manufacturer
    OSSIO LTD.
    Product Code
    OJH
    UDI-DI
    07290019361084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY WAS NOTIFIED OF A REVISION SURGERY. AN INVESTIGATION WAS PERFORMED INCLUDING INTERNAL ANALYSIS OF RECORDS AND SURGEON'S FEEDBACK. SURGEON REPORTED RADIOGRAPHS AND EXAMINATION 3 DAYS FOLLOWING IMPLANTATION SHOWED GOOD BONE ALIGNMENT. PATIENT PLACED IN A SPLINT AND ALLOWED FOR REMOVAL OF SPLINT FOR HYGIENE AND GENTLE ROM. AT DAY 8 PATIENT REPORTED AN IMMEDIATE PAIN FOLLOWING LIGHT ACTIVITY. SURGEON'S EXAMINATION REVEALED IMPLANT WAS BROKEN AT THE FRACTURE SITE. PATIENT NON-COMPLIANCE WITH POST-OPERATIVE REGIME WAS SUSPECTED BUT WAS NOT CONFIRMED BY THE PATIENT. THE DEVICE COULD NOT BE EXAMINED AS IT WAS NOT PROVIDED TO THE COMPANY. NO IMAGING WAS PROVIDED. A REVISION SURGERY WAS PERFORMED WITH A METAL SCREW FOLLOWING REMOVAL OF THE BROKEN IMPLANT BY DRILLING THROUGH. A BACTERIAL INFECTION DEVELOPED AT THE SITE FOLLOWING THE REVISION PROCEDURE, WHICH REQUIRED ADDITIONAL MEDICAL INTERVENTION. THERE IS NO INDICATION OF A DESIGN, MANUFACTURING OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE COMPANY IS UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE THOUGH IT IS LIKELY RELATED TO UNINTENTIONAL NON-COMPLIANCE WITH POST-OPERATIVE CARE REGIME, APPLYING EXCESSIVE FORCE TO THE SURGICAL SITE. 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: #3014323288-2025-00004.

    Description of Event or Problem · 0

    REVISION SURGERY FOLLOWING IMPLANT BREAKAGE 8 DAYS POST METACARPAL FRACTURE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2664259 OSSIOFIBER THREADED TRIMMABLE FIXATION NAIL SYSTEM ORTHOPEDIC TRAY OJH OSSIO LTD. OF04776 07290019361084

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention