BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE LEVEL WP DENTAL IMPLANT Ø4.8X10 MM

    MDR report key: 15689864 · Received October 28, 2022

    Report

    Report Number
    8010516-2022-00121
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    May 13, 2022
    Report Date
    October 28, 2022
    Manufacturer
    HAGER & MEISINGER GMBH
    Product Code
    DZE
    UDI-DI
    E0HM504810WP1
    PMA / PMN Number
    K122807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 OSSEOINTEGRATION, SAME PATIENT AS IN REPORT 8010516-2022-00120.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2871815 TISSUE LEVEL WP DENTAL IMPLANT Ø4.8X10 MM DENTAL IMPLANT DZE HAGER & MEISINGER GMBH 3693728DU0ACE C08538 E0HM504810WP1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Other