BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION

    MDR report key: 9857968 · Received March 19, 2020

    Report

    Report Number
    3007738819-2019-00005
    Event Type
    Injury
    Date Received
    March 19, 2020
    Report Date
    May 4, 2019
    Product Code
    LYC
    UDI-DI
    04560245656821
    PMA / PMN Number
    K111087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    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 EXPIRATION DATE IS DISPLAYED ON THE PRODUCT PACKAGE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IS AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    A DENTIST TREATED A PATIENT BY USING THIS PRODUCT (DENTAL MATERIAL). DURING THE SURGERY, HOWEVER, THE DENTIST MISTAKENLY IMPLANTED A PRODUCT PIECE WHOSE EXPIRATION DATE HAD ALREADY EXPIRED ABOUT 2 YEARS BEFORE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321011 FOUNDATION BONE GRAFTING MATERIAL, SYNTHETIC LYC 27-500-100 M1407E 04560245656821

    Patients

    Seq Age Sex Outcome Treatment
    1