BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSFERION

    MDR report key: 5044126 · Received September 1, 2015

    Report

    Report Number
    3007738819-2015-00013
    Event Type
    Injury
    Date Received
    September 1, 2015
    Report Date
    August 11, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO IRREGULARITIES WERE NOTED. MEANWHILE, WE CANNOT RULE OUT THE POSSIBILITY THAT THIS EVENT WAS CAUSED BY EITHER OTHER INTRAOPERATIVE FACTORS OR OTHER FACTORS RELATED TO POSTOPERATIVE MANAGEMENT. 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: INFECTION. 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

    CASE) A CASE TREATED WITH HIGH TIBIAL OSTEOTOMY (HTO). AFTER THE TIBIAL OSTEOTOMY, THE RESULTANT BONE DEFECT WAS FILLED WITH A PIECE OF BONE VOID FILLER (HEREAFTER, THIS PRODUCT) TRIMMED CORRESPONDING TO THE SHAPE OF THE BONE DEFECT. THEN THE OSTEOTOMIZED TIBIA WAS FIXED WITH A METAL PLATE AND SCREWS ALL OF WHICH ARE EXCLUSIVELY USED FOR INTERNAL FIXATION. AFTER THE SURGERY, HOWEVER, THE PATIENT DEVELOPED A SURGICAL SITE INFECTION. THE SURGEON ADMINISTERED AN ANTIBIOTIC TO THE PATIENT. THE PATIENT IS NOW UNDER FOLLOW-UP OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577812 OSFERION FILLER, BONE VOID, CALCIUM COMPOUND MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY M15402B616

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention