BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 14052326 · Received April 8, 2022

    Report

    Report Number
    2023950-2022-00175
    Event Type
    Injury
    Date Received
    April 8, 2022
    Report Date
    June 8, 2022
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    UDI-DI
    00840481101496
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS THE CLINICIAN'S 2ND ATTEMPT FOR IMPLANT PLACEMENT IN SITE 6. (1ST ATTEMPT (B)(4)). THE 2ND ATTEMPT WAS REMOVED DUE TO LOSS OF INTEGRATION. REPLACEMENT IMPLANT WAS THEN PLACED IN A NEW IMPLANT THE SAME DAY. SITE #5 WAS USED INSTEAD. NON-INTEGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS THE CLINICIAN'S 2ND ATTEMPT FOR IMPLANT PLACEMENT IN SITE 6. (1ST ATTEMPT (B)(4)). THE 2ND ATTEMPT WAS REMOVED DUE TO LOSS OF INTEGRATION. REPLACEMENT IMPLANT WAS THEN PLACED IN A NEW IMPLANT THE SAME DAY. SITE #5 WAS USED INSTEAD. NON-INTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188500 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC 07451 L0A5V 00840481101496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H