BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OKTAGON BLT NC IMPLANT 3.3X8MM

    MDR report key: 12006412 · Received June 16, 2021

    Report

    Report Number
    8010516-2021-00001
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    August 19, 2020
    Report Date
    January 11, 2021
    Manufacturer
    HAGER & MEISINGER GMBH
    Product Code
    DZE
    PMA / PMN Number
    K170287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    POOR OSSEOINTEGRATION OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908493 OKTAGON BLT NC IMPLANT 3.3X8MM DENTAL IMPLANT DZE HAGER & MEISINGER GMBH 3623001DU0000 A98157

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other