BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSFERION

    MDR report key: 5216172 · Received November 11, 2015

    Report

    Report Number
    3007738819-2015-00018
    Event Type
    Injury
    Date Received
    November 11, 2015
    Report Date
    October 21, 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 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 SPINAL FUSION. A PATIENT UNDERWENT SPINAL FUSION WITH SPINAL RODS, SCREWS AND CROSS-LINK. THIS PRODUCT (BONE VOID FILLER) WAS ALSO GRAFTED TO THE SURGICAL SITE. HOWEVER, THE PATIENT DEVELOPED A POSTOPERATIVE INFECTION. THE SURGEON OPENED THE WOUND, REMOVED THE CROSS-LINK, AND THEN IRRIGATED THE LESION. THE PATIENT'S PROGRESS SHOULD CLOSELY BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748808 OSFERION FILLER, BONE VOID, CALCIUM COMPOUND MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY M14709B467

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R