BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5035594 · Received August 26, 2015

    Report

    Report Number
    2023950-2015-00142
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    July 27, 2015
    Report Date
    August 26, 2015
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICIAN STATED THAT LODI IMPLANTS FAILED TO OSSEOINTEGRATE. PATIENT HAS MODERATE DENSITY BONE. THE IMPLANTS WERE NOT IMMEDIATELY LOADED. THE CLINICIAN DID NOT PROVIDE THE FOLLOWING INFORMATION: AMOUNT OF TORQUE USED ON ABUTMENT & IMPLANT AND WHETHER PRIMARY STABILITY WAS ACHIEVED. 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 IS UNKNOWN. THE RECORD'S MANAGEMENT DATABASE OF EACH OF THE ORDERED IMPLANTS INDICATES THAT THE IMPLANTS MET THE SPECIFICATIONS AND WERE APPROVED FOR PRODUCT RELEASE. ANY ISSUES WERE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF THE IMPLANTS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    LODI IMPLANTS FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565907 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC I0VCP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention