BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM 2.4X50MM

    MDR report key: 14239890 · Received April 28, 2022

    Report

    Report Number
    3014554088-2022-00005
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    April 5, 2022
    Report Date
    April 28, 2022
    Manufacturer
    OSSIO LTD.
    Product Code
    HTY
    UDI-DI
    07290017630274
    PMA / PMN Number
    K181180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY WAS INFORMED OF AN IMPLANT REMOVAL SURGERY THAT WAS TO BE PERFORMED 2 MONTHS FOLLOWING AN AKIN OSTEOTOMY PROCEDURE IN THE 1ST RAY. X-RAYS DEMONSTRATE LACK OF BONE ALIGNMENT AND ARE SUGGESTIVE OF BONE INSTABILITY AT THE SURGICAL SITE. NO IMMEDIATE POST-OP IMAGING WAS PROVIDED. SWELLING WAS ATTRIBUTED TO THE UNSTABLE FIXATION OF THE SURGICAL SITE. REMOVAL SURGERY WAS PERFORMED SUCCESSFULLY THE FOLLOWING WEEK. THE ACTUAL DEVICE COULD NOT BE EXAMINED AS IT WAS NOT PROVIDED TO THE COMPANY. A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. BASED ON INTERNAL ANALYSIS OF RECORDS AND PROCEDURES, THERE IS NO INDICATION OF A DESIGN, MANUFACTURING OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. BASED ON THE INVESTIGATION OF ALL AVAILABLE DATA, IT IS CONCLUDED THAT THIS EVENT WAS THE OUTCOME OF AN INAPPROPRIATE SURGICAL FIXATION WHICH RESULTED IN AN UNSTABLE IMPLANTATION SITE. THE INSTRUCTIONS FOR USE INCLUDE PRECAUTIONS AND RECOMMENDATIONS FOR THE SELECTION OF APPROPRIATE SURGICAL TECHNIQUE, IMPLANT SIZE, CONFIGURATION, AND SURGICAL SITE PREPARATION. ALTHOUGH THE COMPANY DOES NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE INJURY, 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.

    Description of Event or Problem · 0

    REMOVAL SURGERY DUE TO LOCAL SWELLING AND IRRITATION 2 MONTHS FOLLOWING AN AKIN OSTEOTOMY PROCEDURE. THE SINGLE OSSIOFIBER TRIMMABLE FIXATION NAIL 2.4X50 MM THAT WAS USED IN THE AKIN OSTEOTOMY WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205343 OSSIOFIBER TRIMMBLE FIXATION NAIL SYSTEM 2.4X50MM FIXATION, PIN, SMOOTH HTY OSSIO LTD. OF2012450S OF01049 07290017630274

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention DYNABUNION LAPIDUS SYSTEM BY CROSSROADS EXTREMITY| OSSIOFIBER COMPRESSION SCREW 4.0X30 MM