BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE IMPLANT OKTAGON 4.1X10MM

    MDR report key: 11918995 · Received June 2, 2021

    Report

    Report Number
    8010516-2021-00033
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    December 23, 2020
    Report Date
    June 2, 2021
    Manufacturer
    HAGER & MEISINGER GMBH
    Product Code
    DZE
    UDI-DI
    E0HM311521
    PMA / PMN Number
    K122807
    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

    PRIMARY STABILITY WAS NOT ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817374 ACE IMPLANT OKTAGON 4.1X10MM DENTAL IMPLANT DZE HAGER & MEISINGER GMBH 3631152DU0ACE B46382 E0HM311521

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other