BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 13064075 · Received December 22, 2021

    Report

    Report Number
    2023950-2021-00468
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    November 17, 2021
    Report Date
    December 21, 2021
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    UDI-DI
    00840481101540
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LOSS OF INTEGRATION. 3 IMPLANTS WERE PLACED (B)(6) 2020 TO SUPPORT IMPLANT SUPPORTED DENTURE. (B)(6) 2021 # 30 WAS LOOSE AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963452 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC 07460 L1BK7 00840481101540

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H