BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSFERION

    MDR report key: 4995767 · Received August 10, 2015

    Report

    Report Number
    3007738819-2015-00010
    Event Type
    Injury
    Date Received
    August 10, 2015
    Report Date
    July 21, 2015
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    MQV
    PMA / PMN Number
    K080065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO IRREGULARITIES WERE NOTED. BECAUSE THE DEVICE (REFERENCED IN THIS REPORT) WAS NOT RETURNED TO OLYMPUS TERUMO BIOMATERIALS CORP. FOR EVALUATION, THE CAUSE OF THE ADVERSE EVENT HAVE NOT BEEN SPECIFIED. THE OSFERION BONE VOID FILLER PACKAGE INSERT STATES IN THE FOLLOWING SECTION: ADVERSE EVENTS: FEVER, PAIN, LOCAL SENSATION, RED FLARE, INFLAMMATION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IS AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    A CASE TREATED WITH HIGH TIBIAL OSTEOTOMY (HTO) DURING THE OPERATION: AFTER OSTEOTOMIZING THE TIBIA, THE SURGEON IN CHARGE OF THE PATIENT IMPLANTED A BONE VOID FILLER (HEREAFTER, THIS PRODUCT), WHICH WAS TRIMMED CORRESPONDING TO THE SHAPE OF THE BONE DEFECT, AND THEN FIXED THE OSTEOTOMIZED TIBIA WITH A METAL PLATE AND SCREWS ALL OF WHICH ARE EXCLUSIVELY USED FOR INTERNAL FIXATION. AFTER THE OPERATION: WHEN REMOVING THE SURGICAL DRAIN 24 HOURS AFTER THE SURGERY, THE SURGEON OBSERVED DISCHARGE OF EXUDATE FROM THE DRAIN HOLE. THE SURGEON STOPPED THE EXUDATE BY APPLYING COMPRESSION FORCE AROUND THE DRAIN HOLE TO FORCIBLY ELIMINATE THE EXUDATE. POSTOPERATIVE COURSE: THE PATIENT HAS NOT MANIFESTED ANY SYMPTOMS OF INFECTION SUCH AS REDNESS AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523127 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY M14Z14B557

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization