BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 8765365 · Received July 5, 2019

    Report

    Report Number
    2023950-2019-00358
    Event Type
    Injury
    Date Received
    July 5, 2019
    Date of Event
    May 30, 2019
    Report Date
    August 20, 2019
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    UDI-DI
    00840481101540
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    NON-INTEGRATION; IMPLANT NOT YET RESTORED; IMPLANT REMOVED. NON-INTEGRATION.

    Description of Event or Problem · 1

    NON-INTEGRATION; IMPLANT NOT YET RESTORED; IMPLANT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559198 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC 07460 L0GJY 00840481101540

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention