BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM, CANNULATED 4.0X70MM

    MDR report key: 20193742 · Received September 11, 2024

    Report

    Report Number
    3014323288-2024-00011
    Event Type
    Injury
    Date Received
    September 11, 2024
    Report Date
    September 11, 2024
    Manufacturer
    OSSIO LTD.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY WAS INFORMED OF AN IMPLANT REVISION SURGERY THAT WAS PERFORMED FOLLOWING AN IMPLANTATION PROCEDURE IN THE PROXIMAL TIBIA. NO IMMEDIATE POST-OP IMAGING WAS PROVIDED. AN MRI IMAGING WAS REPORTED TO HAVE IDENTIFIED A PROUD IMPLANT ON THE MEDIAL SIDE OF THE KNEE. SWELLING AND PAIN WAS ATTRIBUTED TO INCORRECT POSITIONING OF THE IMPLANT. THE PROUD IMPLANT WAS TRIMMED DOWN IN A REVISION SURGERY AT AN UNKNOWN DATE. BASED ON THE INVESTIGATION OF ALL AVAILABLE DATA, IT IS CONCLUDED THAT THIS EVENT WAS THE OUTCOME OF AN IMPROPER SURGICAL PROCEDURE WHICH RESULTED IN AN INCORRECT POSITIONING OF THE IMPLANT I.E. PROUD MEDIALLY. THE INSTRUCTIONS FOR USE INCLUDE PRECAUTIONS AND RECOMMENDATIONS FOR THE SELECTION OF APPROPRIATE SURGICAL TECHNIQUE, IMPLANT SIZE, CONFIGURATION, AND SURGICAL SITE PREPARATION. AS A REVISION 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 MANUFACTURER RELATING TO THIS EVENT IS: #3014554088-2024-00011.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO PAIN AND SWELLING FOLLOWING IMPLANTATION IN THE PROXIMAL TIBIA. A PROUD OSSIOFIBER CANNULATED TRIMMABLE FIXATION NAIL 4.0X70 MM WAS TRIMMED DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621814 OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM, CANNULATED 4.0X70MM FIXATION, PIN, SMOOTH HTY OSSIO LTD. OF2054070S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention OSSIOFIBER TRIMMABLE FIXAITON NAIL, CANNULATED.