BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSFERION

    MDR report key: 3622138 · Received January 29, 2014

    Report

    Report Number
    3007738819-2014-00001
    Event Type
    Other
    Date Received
    January 29, 2014
    Report Date
    January 4, 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 (REF IN THIS REPORT) WAS NOT RETURNED TO OLYMPUS TERUMO BIOMATERIALS CORP. FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO IRREGULARITIES WERE NOTED. FOREIGN BODY REACTION AND MIGRATION OF THIS PRODUCT MAY BE ATTRIBUTABLE TO POOR FIXATION. HOWEVER, THE CAUSE OF THESE ADVERSE EVENTS HAS NOT BEEN SPECIFIED. THE OSFERION BONE VOID FILLER PACKAGE INSERT STATES IN THE WARNING AND PRECAUTION SECTION: IF NECESSARY, THE FRACTURE SHOULD BE STABILIZED USING EXTERNAL OR INTERNAL FIXATIONS TO PREVENT POST-IMPLANTATION MIGRATION OR EXTRUSION OF THE OSFERION DUE TO LOOSENING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IS AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    DURING A HIGH TIBIAL OSTEOTOMY (HTO), THE SURGEON REALIZED AN INTRAOPERATIVE FRACTURE AT THE OPERATION SITE. THEREFORE, THE SURGEON CARRIED OUT INTERNAL FIXATION USING A BONE PLATE IN A MANNER DIFFERENT FROM A NORMAL PATTERN AND IMPLANTED ONE PIECE OF THIS PRODUCT TRIMMED INTO A WEDGE (HEREAFTER, THE FIRST PRODUCT). ABOUT SIX WEEKS AFTER THE OPERATION, IT WAS REVEALED THAT THE FIRST PRODUCT WAS DISPLACED AND MIGRATED BENEATH AND ALONGSIDE THE BONE PLATE TOWARD DISTAL TIBIA. THUS, THE SURGEON CARRIED OUT THE REOPERATIVE SURGERY AND NEWLY PACKED THE SPACE WITH A DIFFERENT THIS PRODUCT THAT WAS CRUSHED INTO GRANULES (HEREAFTER, THE SECOND PRODUCT). DESPITE AN ELEVATED CRP LEVEL, THE PT NEITHER DEVELOPED FEVER NOR DEMONSTRATED THE FOOT SWELLING. THEREFORE, THE SURGEON DETERMINED TO OBSERVE THE PT'S CONDITION. ABOUT ONE WEEK AFTER THE REOPERATIVE SURGERY, IT BECAME CLEAR THAT THE SECOND PRODUCT WAS ALSO DISPLACED AND MIGRATED BENEATH THE BONE PLATE. THE CRP VALUE WAS 0.11, WHICH WAS REGARDED AS LITTLE PROBLEMATIC. ALTHOUGH EXUDATE DUE TO FOREIGN BODY REACTION APPARENTLY EXISTS AROUND THE REGION WHERE THIS PRODUCT WAS IMPLANTED, THE PT HAS NEITHER COMPLAINED OF PAIN OR DEMONSTRATED SIGNS OF INFECTION. THE PT IS EXAMINED REGULARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63783 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION M13404B191, M12Z08B140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R