BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5035600 · Received August 26, 2015

    Report

    Report Number
    2023950-2015-00139
    Event Type
    Injury
    Date Received
    August 26, 2015
    Report Date
    August 25, 2015
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICIAN STATED THAT LODI IMPLANT FAILED TO INTEGRATE A YEAR AFTER IT WAS PLACED. THE CLINICIAN DID NOT PROVIDE THE FOLLOWING INFORMATION: AMOUNT OF TORQUE USED ON ABUTMENT & IMPLANT, PATIENT BONE DENSITY, WHETHER PRIMARY STABILITY WAS ACHIEVED, AND WHETHER IMPLANT WAS IMMEDIATELY LOADED. FAILURE TO OSSEOINTEGRATE IS A WELL-DOCUMENTED INHERENT RISK OF DENTAL IMPLANTS. IN THE MAJORITY OF CASES WHERE AN IMPLANT FAILS TO INTEGRATE W/THE BONE AND IS REJECTED BY THE BODY, THE CAUSE MAY BE UNKNOWN. THE IMPLANT'S LOT HISTORY RECORDS WERE REVIEWED; ANY DISCREPANCIES OR ISSUES OR NON-CONFORMANCE WERE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF THE PARTS. IMPLANT WAS MFR'D TO SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    LOSS OF INTEGRATION; IMPLANT FAILED ONE YEAR AFTER PLACEMENT. INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565911 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC I0M5V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention