BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSFERION

    MDR report key: 3425072 · Received October 18, 2013

    Report

    Report Number
    3007738819-2013-00003
    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.

    Description of Event or Problem · 1

    HIGH TIBIAL OSTEOTOMY (THO) WAS PERFORMED. AFTER SIX MONTHS OF THE TREATMENT, THE PT WAS DIAGNOSED AS HAVING INFECTION. THE PT WAS GIVEN AN ORAL DOSE OF ANTIBIOTICS. AFTER THE COURSE OF ANTIBIOTICS, THE SYMPTOM WAS REDUCED AND THE PT LEFT THE HOSP. THE DOCTOR ASSUMES THAT THE INFECTION WAS NOT CAUSED BY THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534954 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION M11Y02A834

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization