BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 14060274 · Received April 8, 2022

    Report

    Report Number
    2023950-2022-00183
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    January 3, 2022
    Report Date
    April 26, 2022
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    UDI-DI
    00840481101519
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DOCTOR REPORTED LOSS OF INTEGRATION. INITIALLY IMPLANTS WERE PLACED ACHIEVING PRIMARY STABILITY. AFTER 1 MONTH, OSSEOINTEGRATION WAS OBSERVED. AFTER 2 MONTHS, IMPLANTS PRESENTED MOBILITY AND WERE REMOVED. LOOS OF INTEGRATION.

    Description of Event or Problem · 0

    DOCTOR REPORTED LOSS OF INTEGRATION. INITIALLY IMPLANTS WERE PLACED ACHIEVING PRIMARY STABILITY. AFTER 1 MONTH, OSSEOINTEGRATION WAS OBSERVED. AFTER 2 MONTHS, IMPLANTS PRESENTED MOBILITY AND WERE REMOVED. LOOS OF INTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488724 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC 07455 L1PN7 00840481101519

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H