BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION CPS BIOABSORBABLE MESH PLATES

    MDR report key: 10579082 · Received September 24, 2020

    Report

    Report Number
    3003407235-2020-00004
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    October 2, 2017
    Report Date
    September 23, 2020
    Manufacturer
    INION OY
    Product Code
    JEY
    PMA / PMN Number
    K010352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INION CPS® MESH PLATE WAS USED IN ORBITAL FLOOR REPAIR FOR A (B)(6) YEAR OLD MAN. FLUID ACCUMULATION WAS NOTICED 2.5 MONTHS POST OPERATIVELY, AND 3.5CC OF FLUID WAS DRAINED OUT BY PERCUTANEOUS NEEDLE ASPIRATION. THE NEEDLE ASPIRATION WAS REPEATED 3 TIMES DURING 8 - 10 MONTHS POST OPERATIVELY. NO GROWTH OF BACTERIA HAS BEEN FOUND IN FLUID COLLECTION. THE NUMBER OF PATIENTS EXPERIENCING THIS TYPE OF TISSUE REACTION IS VERY LOW. OCCURRENCE RATE OF DEGRADATION RELATED TISSUE REACTIONS (INION CPS®) IS 0,15 % AS REPORTED TO INION. FLUID ACCUMULATION IS A KNOWN ADVERSE EVENT WITH THE BIOABSORBABLE IMPLANTS, ESPECIALLY IF METABOLISM/VASCULARITY IS LOCALLY REDUCED OR POOR. TISSUE REACTIONS SUCH AS THIS ARE RARE, BUT MAY OCCUR 1-2 YEARS POSTOPERATIVELY WHEN THE DEVICE STARTS TO DEGRADE, ESPECIALLY WHEN A PLATE IS IMPLANTED UNDER A THIN SOFT TISSUE LAYER. SUCH REACTION DOES NOT AFFECT BONE HEALING NEGATIVELY, OR CAUSE PERMANENT DAMAGE OR IMPAIRMENT. THE OCCURRENCE RATE OF DEGRADATION RELATED TISSUE REACTIONS HAS BEEN REPORTED TO BE VERY LOW WITH POLYLACTIC ACID BASED IMPLANTS, WHICH IS IN LINE WITH INION'S POST MARKET DATA.

    Description of Event or Problem · 1

    INION CPS® MESH PLATE WAS USED IN ORBITAL FLOOR REPAIR FOR A (B)(6) YEAR OLD MAN. FLUID ACCUMULATION WAS NOTICED 2.5 MONTHS POST OPERATIVELY, AND 3.5CC OF FLUID WAS DRAINED OUT BY PERCUTANEOUS NEEDLE ASPIRATION. THE NEEDLE ASPIRATION WAS REPEATED 3 TIMES DURING 8 TO 10 MONTHS POST OPERATIVELY. NO GROWTH OF BACTERIA HAS BEEN FOUND IN FLUID COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048106 INION CPS BIOABSORBABLE MESH PLATES BONA PLATE JEY INION OY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention