BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5229084 · Received July 13, 2015

    Report

    Report Number
    2023950-2015-00100
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    April 13, 2015
    Report Date
    July 13, 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
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICIAN STATED THAT LODI IMPLANT FAILED TO OSSEOINTEGRATE. THE IMPLANTS WERE NOT IMMEDIATELY LOADED, BUT WERE PLACED INTO A PREVIOUSLY SIMULTANEOUSLY GRAFTED SITE AND AN IMMEDIATE EXTRACTION SITE. THE CLINICIAN DID NOT PROVIDE THE FOLLOWING INFORMATION: AMOUNT OF TORQUE USED ON ABUTMENT AND 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 RECORDS MANAGEMENT DATABASE SPECIFIES THAT THE IMPLANTS MET THE SPECIFICATIONS AND WERE APPROVED FOR PRODUCT RELEASE. ANY ISSUES WERE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF THE IMPLANTS. IMPLANTS WERE MANUFACTURED TO SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED. NOTE: INITIALLY SENT TO FDA ON 05/28/2015 UNDER MDR REF. NO. 2023950-2015-000073.

    Description of Event or Problem · 1

    LODI IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454565 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS,LLC IORU5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention