BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSFERION

    MDR report key: 3368459 · Received September 19, 2013

    Report

    Report Number
    3007738819-2013-00002
    Event Type
    Other
    Date Received
    September 19, 2013
    Report Date
    August 22, 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 EVALUATION. 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 NOT 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 IS AN ABUNDANCE OF CAUTION. LOT# EITHER LOT #M12X03B085 OR LOT # M124914B098 WAS USED. EXPIRATION DATE: 01/01/2018 OR 02/01/2018.

    Description of Event or Problem · 1

    IN THE SURGICAL TREATMENT FOR A PATIENT WITH ATLANTOAXIAL SUBLUXATION, A BONE GRAFT WAS TAKEN FROM THE PATIENT'S POSTERIOR ILIAC BONE (HALF LAYER) FOR THE FIXATION OF CERVICAL SPINE. THIS DEVICE WAS IMPLANTED TO FILL THE DEFICIT FORMED IN THE DONOR SITE. BONE WAX WAS USED TOGETHER. AFTER THE TREATMENT, THE PATIENT COMPLAINED OF PAIN IN THE DONOR SITE. WITH THE ELEVATED CRP LEVEL, THE PATIENT WAS DIAGNOSED AS HAVING (B)(6) INFECTION. THE SECOND SURGERY WAS CARRIED OUT TO REMOVE THIS PRODUCT. AFTER THE DEVICE WAS REMOVED, THE PATIENT WAS RECOVERED. THE DOCTOR THINKS THAT THE INFECTION RISKS (BLOOD FLOW OBSTRUCTION) WERE PRESUMABLY INCREASED NOT BY THIS PRODUCT, BUT BY THE COMBINED USE OF TWO DIFFERENT TYPES OF FOREIGN MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472358 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION M12X03B085

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization