BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIOFIBER HAMMERTOE FIXATION SYSTEM, S, 2.5 X 16 MM, STRAIGHT

    MDR report key: 14468200 · Received May 23, 2022

    Report

    Report Number
    3014554088-2022-00006
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    April 26, 2022
    Report Date
    May 23, 2022
    Manufacturer
    OSSIO LTD.
    Product Code
    HTY
    PMA / PMN Number
    K190652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THE SURGEON'S FEEDBACK. THE DEVICE COULD NOT BE EXAMINED AS IT WAS NOT PROVIDED TO THE COMPANY. NO IMMEDIATE POST-OPERATIVE IMAGING WAS PROVIDED. NO INFORMATION ON CLINICAL SYMPTOMS WAS SHARED. THERE IS NO INDICATION OF A DESIGN, MANUFACTURING OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. IT WAS NOTED THAT THE IMPLANT BROKE, BUT IT IS UNKNOWN WHETHER THE IMPLANT WAS FOUND BROKEN OR BROKE DURING THE REMOVAL SURGERY. TWO ADDITIONAL IMPLANTS OF THE SAME SIZE WERE IMPLANTED IN 2 OTHER TOES DURING THE INITIAL PROCEDURE, WITH NO ISSUE REPORTED. THE ROOT CAUSE OF THE REVISION SURGERY COULD NOT BE DETERMINED BUT IS LIKELY LINKED TO INADEQUATE BONE FIXATION AT TIME OF SURGERY OR INAPPROPRIATE POST OPERATIVE CARE (I.E., ADDITIONAL IMMOBILIZATION) WHICH MAY LEAD TO UNSTABLE FIXATION AND RESULT IN REVISION SURGERY. HOWEVER, 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 INITIAL IMPORTER RELATING TO THIS EVENT IS: #3014323288-2022-00006.

    Description of Event or Problem · 0

    HAMMERTOE REVISION SURGERY, 3RD TOE, 4 MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582693 OSSIOFIBER HAMMERTOE FIXATION SYSTEM, S, 2.5 X 16 MM, STRAIGHT FIXATION, PIN, SMOOTH HTY OSSIO LTD. OF20025160

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention OSSIOFIBER® HAMMERTOE FIXATION SYSTEM 2.5X16MM, 0°| OSSIOFIBER® HAMMERTOE FIXATION SYSTEM 2.5X16MM, 0°