BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSFERION

    MDR report key: 2820831 · Received October 29, 2012

    Report

    Report Number
    3007738819-2012-00009
    Event Type
    Other
    Date Received
    October 29, 2012
    Report Date
    October 1, 2012
    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 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 IS AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE PRODUCT WAS USED IN COMBINATION WITH LOCAL BONE FOR SCOLIOSIS SURGERY. METAL FIXATIONS MANUFACTURED BY (B)(4) WERE ALSO USED. POST-OPERATIVE FEVER WAS PROLONGED WITHOUT REMISSION AND REOPERATIVE SURGERY WAS PERFORMED. DEBRIDEMENT WAS PERFORMED AND THE SITE WAS IMPLANTED WITH LOCAL BONE AND THE PRODUCT NEWLY OPENED. IT IS UNKNOWN HOW THE METAL FIXATIONS WERE HANDLED. THE PRIMARY PHYSICIAN DID NOT CONSIDER THAT OSFERION CAUSED THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION M12309A933

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R