BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTAGON BL IMPLANT NP 3.3X10

    MDR report key: 11911390 · Received June 1, 2021

    Report

    Report Number
    8010516-2021-00030
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Report Date
    June 1, 2021
    Manufacturer
    HAGER & MEISINGER GMBH
    Product Code
    DZE
    UDI-DI
    E0HM22010DU0ACE1
    PMA / PMN Number
    K143539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.

    Description of Event or Problem · 1

    THE CUSTOMER HAS NOT USED THE IMPLANT DUE TO THE IMPRESSION OF OIL N THE IMPLANT SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814012 OCTAGON BL IMPLANT NP 3.3X10 DENTAL IMPLANT DZE HAGER & MEISINGER GMBH 3622010DU0ACE B96242 E0HM22010DU0ACE1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other