BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSFERION

    MDR report key: 4922307 · Received July 14, 2015

    Report

    Report Number
    3007738819-2015-00007
    Event Type
    Injury
    Date Received
    July 14, 2015
    Report Date
    June 19, 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 IS A SUPPLEMENTAL REPORT FOR MFR REPORT #3007738819-2015-00007 TO PROVIDE ADDITIONAL INFORMATION. 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. CONSIDERING THAT THIS EVENT APPEARED EIGHT MONTHS AFTER SURGERY, THIS EVENT MAY HAVE A RELATION WITH A PREDISPOSITION OF THIS PATIENT OR MAY BE CAUSED BY SOME SORT OF POSTOPERATIVE ABNORMALITY. HOWEVER,THE CAUSE OF THIS ADVERSE EVENT HAS NOT BEEN SPECIFIED BECAUSE WE ARE UNABLE TO DIRECTLY EXAMINE THIS PRODUCT IMPLANTED.

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IN THIS REPORT WAS NOT RETURNED TO US FOR EVALUATION, WE WERE NOT ABLE TO DEFINE THE ROOT CAUSE OF THE EVENT. THE OSFERION BONE VOID FILLER PACKAGE INSERT STATES IN THE FOLLOWING SECTION. 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 PATIENT UNDERGOING THE OPERATION OF HIGH TIBIAL OSTEOTOMY. HOWEVER, THE PATIENT DEVELOPED SYMPTOM OF AN INFLAMMATION OF SKIN AFTER THE OPERATION.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT HIGH TIBIAL OSTEOTOMY (HTO) WITH A BONE VOID FILLER(THIS PRODUCT). THIS PRODUCT WAS TRIMMED INTO A WEDGED SHAPE AND IMPLANTED INTO THE BONE DEFECT CREATED AFTER OSTEOTOMY. AFTER THE IMPLANTATION, THIS PRODUCT WAS COVERED WITH PERIOSTEUM AND SOFT TISSUES. THE OSTEOMIZED TIBIA WAS FIXED WITH A METAL PLATE FOR INTERNAL FIXATION. HOWEVER, EIGHT MONTHS AFTER THE SURGERY, DERMATITIS (SKIN DISCOLORATION AND ITCHING) APPEARED AT THE SURGICAL SITE, RESULTING IN POSTINFLAMMATORY HYPERPIGMENTATION. AFTERWARDS THE AREA OF HYPERPIGMENTATION BECAME SMALL AND THE HYPERPIGMENTATION FADED GRADUALLY. THE PATIENT'S ITCHING WAS ALSO IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457816 OSFERION MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY 60A4 M10414A444

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention