BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSFERION

    MDR report key: 3982946 · Received July 14, 2014

    Report

    Report Number
    3007738819-2014-00004
    Event Type
    Other
    Date Received
    July 14, 2014
    Report Date
    June 18, 2014
    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. AS THE STERILITY OF THIS DEVICE HAS BEEN ASSURED BY THE STERILIZATION VALIDATION, THERE IS NO POSSIBILITY OF THIS DEVICE BECOMING THE IMMEDIATE CAUSE OF INFECTION. BACTERIUM MAY INVADE AT VARIOUS OPPORTUNITIES SUCH AS DURING THE SURGICAL PROCEDURE AND DURING THE POSTOPERATIVE NON-STERILIZED PROCEDURE, AND THROUGH VARIOUS ROUTES SUCH AS INVASION FROM THE WOUND. MOREOVER, THIS DEVICE CONSISTS OF BETA-TRICALCIUM PHOSPHATE (CERAMIC). THEREFORE, THIS DEVICE WOULD HARDLY BECOME THE CAUSATIVE AGENT OF ALLERGY. HOWEVER, THE CAUSE OF THESE ADVERSE EVENTS HAVE NOT BEEN SPECIFIED. THE OSFERION BONE VOID FILLER PACKAGE INSERT STATES IN THE ADVERSE EVENTS SECTION: INFECTION, NONUNION, FRACTURE, 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

    THIS PRODUCT WAS IMPLANTED IN A PT UNDERGOING THE OPERATION OF HIGH TIBIAL OSTECTOMY. HOWEVER, THE PT DEVELOPED SYMPTOMS OF INFECTION AND ALLERGY APPROX SIX MONTHS AFTER THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410215 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION M12406A938

    Patients

    Seq Age Sex Outcome Treatment
    1