BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 3181493 · Received June 14, 2013

    Report

    Report Number
    2023950-2013-00006
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ZEST ANCHORS, INC.
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 IMPLANTS WERE 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 OF 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. IT WAS NOTED THAT THE PATIENT HAD MEDIUM DENSITY BONE, TYPE II. THE IMPLANTS' LOT HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES OR ISSUES OF NON-CONFORMANCE WERE NOTED. IMPLANTS 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
    270734 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. 19972

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention