BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5350460 · Received January 4, 2016

    Report

    Report Number
    2023950-2016-00004
    Event Type
    Injury
    Date Received
    January 4, 2016
    Report Date
    January 4, 2016
    Manufacturer
    ZEST ANCHORS, INC.
    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 IMPLANTS FAILED TO OSSEOINTEGRATE. THE CLINICIAN DID NOT PROVIDE THE FOLLOWING INFORMATION: AMOUNT OF TORQUE USED ON ABUTMENT AND 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 RECORDS MANAGEMENT DATABASE INDICATES THAT THE IMPLANTS MET ALL 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. REFER TO PER (B)(4).

    Description of Event or Problem · 1

    LODI IMPLANT FAILED TO OSSEOINTEGRATE. THE FOLLOWING IS THE INFORMATION ON THE IMPLANTS: P/N 07461, LOT #21614: 04/30/2018 (EXP), 06/01/2013 (MFR). P/N 07466, LOT #21131: 03/31/2018 (EXP), 05/01/2013 (MFR). . INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. 21614

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention