BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION OTPS MINI BIOABSORBABLE PLATES

    MDR report key: 5589908 · Received April 20, 2016

    Report

    Report Number
    9710629-2016-00002
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    January 29, 2016
    Report Date
    April 20, 2016
    Manufacturer
    INION OY
    Product Code
    HRS
    PMA / PMN Number
    K023887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER PRODUCTS USED IN THE OPERATION: FRF-1014, (B)(4). FRF-1284, (B)(4). FRF-1207, LOT: 1210038, (B)(4). TISSUE REACTION IS AN ANTICIPATED ADVERSE EVENT, ALSO IDENTIFIED IN THE RISK ANALYSIS OF THESE PRODUCTS. THE OCCURRENCE RATE IS BEING FOLLOWED AND CONTINUOUSLY LOW. THIN SOFT TISSUE COVERAGE OVER THE IMPLANT MAY INCREASE THE RISK OF TISSUE REACTION. THE UPPER PLATE WAS HERE PLACED JUST UNDER THE GUM. THE PATIENT HAS RECEIVED CHEMOTHERAPY AND RADIOTHERAPY AFTER THE SURGERY FOR CANCER TREATMENT. THIS MAY HAVE CONTRIBUTED TO THE TISSUE REACTION AND BONE EROSION.

    Description of Event or Problem · 1

    THE PATIENT WAS DIAGNOSED WITH "TONGUE SQUAMOUS CELL CARCINOMA, WITH CERVICAL LYMPH NODE METASTASIS(T1N2M0)", AND OPERATED ON (B)(6) 2015. DURING THE OPERATION, THE MANDIBLE WAS SPLIT INTO TWO PARTS IN ORDER TO REMOVE THE PRIMARY LESION AND ALL THE METASTASES OF THE CARCINOMA. IN ORDER TO OPERATE THE TONGUE, OSTEOTOMY WAS PERFORMED ON THE MANDIBLE. EVENTUALLY, THE TWO PARTS WERE FIXED BY INION PRODUCTS. THE SURGERY WENT WELL, AND THERE WERE NO COMPLICATIONS DURING THE FOLLOWING MONTHS. ABOUT 8 MONTHS LATER, BONE RESORPTION WAS DETECTED. A FISTULA FORMED WITH PUS LEAKING FROM THE MOUTH, THE JAW, AND THROUGH THE SKIN. THE PLATES AND SCREWS WERE REMOVED. THE PATIENT HAD CHEMOTHERAPY AND RADIATION THERAPY AFTER SURGERY, WHICH MAY HAVE AFFECTED THE LOCAL BONE QUALITY AND/OR VASCULARITY, AND THUS CONTRIBUTED TO THE OBSERVED REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242927 INION OTPS MINI BIOABSORBABLE PLATES BONE FIXATION PLATE HRS INION OY 1310041

    Patients

    Seq Age Sex Outcome Treatment
    1 Other