BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSFERION

    MDR report key: 9857966 · Received March 19, 2020

    Report

    Report Number
    3007738819-2017-00018
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    November 13, 2017
    Report Date
    November 13, 2017
    Manufacturer
    OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    MQV
    PMA / PMN Number
    K080065
    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 OSFERION BONE VOID FILLER PACKAGE INSERT STATUS IN THE WARNING AND PRECAUTION SECTION: (11) OSFERION MUST NOT BE USED AFTER THE EXPIRATION DATE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IS AN ABUNDANCE OF CAUTION. WE SUBMITTED THE INITIAL REPORT ON DEC 4TH 2017. THIS IS RESUBMISSION.

    Description of Event or Problem · 1

    DEVICE USED AFTER EXPIRATION DATE. A DEVICE PAST EXPIRY WAS IMPLANTED DURING SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320994 OSFERION FILLER, BONE VOID, CALCIUM COMPOUND MQV OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY M12313A906

    Patients

    Seq Age Sex Outcome Treatment
    1