BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE LEVEL IMPLANT REGULAR PLATFORM Ø4,8X10

    MDR report key: 15333218 · Received September 1, 2022

    Report

    Report Number
    8010516-2022-00112
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    April 5, 2022
    Report Date
    April 5, 2022
    Manufacturer
    HAGER & MEISINGER GMBH
    Product Code
    DZE
    UDI-DI
    E0HM5048101
    PMA / PMN Number
    K122807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    MISSING PRIMARY STABILITY. "BUCCAL DEFECT SURGEON TRIED 3 IMPLANTS; NONE OF THEM ENGAGED, PROBABLY NOT ENOUGH THREAD, DECIDED TO GRAFT FIRST AND WAIT 3-4 MONTH" SEE ALSO REPORTS 8010516-2022-00113 AND 8010516-2022-00114.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2823174 TISSUE LEVEL IMPLANT REGULAR PLATFORM Ø4,8X10 DENTAL IMPLANT DZE HAGER & MEISINGER GMBH 3650347DU0ACE B41510 E0HM5048101

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other