BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 3082439 · Received April 25, 2013

    Report

    Report Number
    2023950-2013-00004
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ZEST ANCHORS, INC.
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    USER DOCUMENTATION (TECHNIQUE MANUAL, P/N L8019-TM) SPECIFIES THAT IMMEDIATE LOADING IS SUITABLE ONLY IF SUFFICIENT PRIMARY STABILITY OF THE IMPLANT IS ACHIEVED AT THE TIME OF PLACEMENT. FURTHERMORE, THE IMPLANT SYSTEM REQUIRES A TORQUE OF AT LEAST 30N-CM. THE IMPLANT WAS PLACED ON (B)(6) 2013 AND THE HEALTHCARE PROFESSIONAL NOTED THAT IT FAILED TO OSSEOINTEGRATE. IMPLANT WAS REMOVED ON (B)(6) 2013. FAILURE TO OSSEOINTEGRATE IS A WELL-DOCUMENTED INHERENT RISK AND DENTAL IMPLANTS. THE HEALTHCARE PROFESSIONAL DID NOT INDICATE THE FOLLOWING: WHETHER THE IMPLANT WAS EVER LOADED WITH THE OVERDENTURE; WHETHER PRIMARY STABILITY HAD BEEN ACHIEVED DURING IMPLANT PLACEMENT; DID NOT SPECIFY THE PATIENT'S BONE DENSITY IN THE AREA WHERE IMPLANT WAS PLACED. IT WAS NOTED THAT THE PATIENT WAS DIAGNOSED WITH LUNG CANCER AND MAY HAVE ADVERSELY AFFECTED THE EFFECTIVENESS OF THE DEVICE. THE IMPLANTS' LOT HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES OR ISSUES OF NON-CONFORMANCE WERE NOTED. IMPLANT WAS MANUFACTURED TO SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180173 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. 21978

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention