BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSFERION

    MDR report key: 3425059 · Received October 18, 2013

    Report

    Report Number
    3007738819-2013-00004
    Event Type
    Other
    Date Received
    October 18, 2013
    Report Date
    September 19, 2013
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE (REFERENCED IN THIS REPORT) WAS NOT RETURNED TO OLYMPUS TERUMO BIOMATERIALS CORP FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO IRREGULARITIES WERE NOTED. THE STERILITY OF THIS DEVICE HAS BEEN ASSURED THROUGH THE STERILIZATION VALIDATION. THEREFORE, THERE IS NO POSSIBILITY THAT THIS PRODUCT IMMEDIATELY CAUSED THE ADVERSE EVENT IN THIS REPORTED CASE. THE OSFERION BONE VOID FILLER PACKAGE INSERT STATES IN THE ADVERSE EVENTS SECTION: INFECTION, NONUNION, FRACTURE, FEVER, PAIN, LOCAL SENSATION, RED FLARE, INFLAMMATION. POSSIBLE ADVERSE EVENTS INCLUDE BUT ARE NO LIMITED TO: SUPERFICIAL WOUND INFECTION, DEEP WOUND INFECTION, WOUND DEHISCENCE, DELAYED UNION, MALUNION, LOSS OF REDUCTION, CYST RECURRENCE, HEMATOMA, CELLULITIS, CONGLUTINATE FAILURE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    HIGH TIBIAL OSTEOTOMY (THO) WAS PERFORMED. AFTER FIVE MONTHS OF THE TREATMENT, THE PT WAS DIAGNOSED AS HAVING AN INFECTION. THE SECOND SURGERY WAS CARRIED OUT TO REMOVE THE METAL IMPLANT. AFTER THE SECOND SURGERY, THE SYMPTOM OF THE INFECTION WAS REDUCED. THE DOCTOR ASSUMES THAT THE INFECTION WAS NOT CAUSED BY THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535745 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION M12717A984

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization