BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSFERION

    MDR report key: 3688095 · Received February 26, 2014

    Report

    Report Number
    3007738819-2014-00002
    Event Type
    Other
    Date Received
    February 26, 2014
    Report Date
    January 31, 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 EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO IRREGULARITIES WERE NOTED. THE REASON WHY THIS PRODUCT WAS NOT REPLACED BY AUTOGENOUS BONE IS PROBABLY BECAUSE THE SURGEON WAS UNABLE TO IMPLANT THIS PRODUCT IN SUCH A WAY THAT THE PRODUCT DIRECTLY CONTACTS THE VITAL BONE TO SECURE BLOOD FLOW. HOWEVER, WE HAVE NOT BEEN ABLE TO IDENTIFY THE CAUSE OF THE NON-UNION. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IS AN ABUNDANCE OF CAUTION. ADDITIONAL LOT # M13906B269; IMPLANT DATE: (B)(6) 2013.

    Description of Event or Problem · 1

    A PATIENT WITH OLD MONTEGGIA FRACTURE WAS TREATED BY OSTEOTOMY AND INTERNAL FIXATION WITH A PLATE AND SCREWS. A GAP FORMED AFTER THE OSTEOTOMY WAS FILLED WITH THIS PRODUCT (HEREAFTER, THE FIRST PRODUCT). POST-OPERATIVE RADIOGRAPHS TAKEN AFTER 3-4 MONTHS SHOWED THAT THE FIRST PRODUCT HAD NOT YET BEEN REPLACED BY AUTOGENOUS BONE, AND THAT THERE WAS NO FAVORABLE CHANGE AT THE GAP. THEREFORE, THE SURGEON CARRIED OUT THE REOPERATIVE SURGERY, CONSIDERING THAT THE OSTEOTOMY SITE WAS IN A STATE OF NON-UNION. AFTER REMOVING THE PLATE, SCREWS AND THE FIRST PRODUCT, THE SURGEON FIXED THE OSTEOTOMY SITE WITH ANOTHER SET OF PLATE AND SCREWS, AND TRANSPLANTED BONE TISSUE HARVESTED FROM THE PATIENT'S ILIUM INTO THE GAP. ANOTHER PRODUCT (HEREAFTER, THE SECOND PRODUCT) WAS IMPLANTED INTO THE RESULTANT BONE DEFECT IN THE HARVESTED AREA. AFTERWARDS THE PATIENT ACHIEVED BONE UNION, WHO IS MAKING SATISFACTORY RECOVERY. DOCTORS' COMMENTS: THE CAUSE OF THE NON-UNION IS UNCLEAR. HOWEVER, RADIOGRAPHIC IMAGES SUGGEST THAT TISSUE SURROUNDING THE BONE SURFACE, SUCH AS PERIOSTEUM, WAS SEVERED BY THE OSTEOTOMY, WHICH RESULTED IN THE LOSS OF CONTACT BETWEEN THE BONE FRAGMENTS. GIVEN THESE FACTS, THERE IS A POSSIBILITY THAT ANATOMICAL AND HISTOLOGICAL CONDITION OF THE GRAFT-RECIPIENT SITE WAS TOO POOR FOR IMPLANTATION OF THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117981 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY OSFERION M12Y04B140

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R