BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 3080275 · Received April 24, 2013

    Report

    Report Number
    2023950-2013-00003
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    March 15, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ZEST ANCHORS, INC.
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, ON HIGH DENSITY BONE (D1) AND THE HEALTHCARE PROFESSIONAL NOTED THAT THEY FAILED TO OSSEOINTEGRATE. ONE IMPLANT WAS REMOVED ON (B)(6) 2013 AND THE OTHER TWO IMPLANTS WERE REMOVED ON (B)(6) 2013. ACCORDING TO THE CLINICIAN, THE IMPLANTS WERE NEVER LOADED AND THAT IT IS LIKELY THAT PRIMARY STABILITY MAY NOT HAVE BEEN ACHIEVED DURING IMPLANT PLACEMENT. ALSO, DOES NOT SPECIFY IF MINIMUM REQUIRED TORQUE (30 N-CM) WAS APPLIED. NO SIGNIFICANT FINDINGS REGARDING PATIENT MEDICAL HISTORY. FAILURE TO OSSEOINTEGRATE IS A WELL-DOCUMENTED INHERENT RISK OF DENTAL IMPLANTS. IT IS ACCEPTED BY THE DENTAL INDUSTRY THAT THIS ISSUE WILL OCCASIONALLY OCCUR AND IN THE MAJORITY OF CASES WHERE AN IMPLANT FAILS TO INTEGRATE WITH THE BONE AND IS REJECTED BY THE BODY THE CAUSE IS UNKNOWN. THE IMPLANTS' LOT HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES OR ISSUES OR NON-CONFORMANCE WERE NOTED. IMPLANTS WERE MANUFACTURED TO SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THREE IMPLANTS FAILED TO OSSEOINTEGRATE AND WERE NEVER LOADED WITH THE OVERDENTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177156 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. 19969, 19642, 19537

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention