BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 4823670 · Received June 4, 2015

    Report

    Report Number
    2023950-2015-00076
    Event Type
    Injury
    Date Received
    June 4, 2015
    Date of Event
    April 16, 2015
    Report Date
    June 4, 2015
    Manufacturer
    ZEST ANCHORS, INC.
    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

    USER DOCUMENTATION (TECHNIQUE MANUAL, (B)(4)) SPECIFIES THAT IMMEDIATE LOADING IS SUITABLE ONLY IF SUFFICIENT PRIMARY STABILITY OF THE IMPLANT IS ACHIEVED AT THE TIME OF PLACEMENT. ALSO, THE RECOMMENDED IMPLANT INSERTION TORQUE AND IMPLANT ATTACHMENT TORQUE IS 30N-CM. IF THE IMPLANT PLACEMENT TORQUE IS LESS THAN 30N-CM, THEN THE ATTACHMENTS SHOULD ONLY BE HAND TIGHTENED. THE IMPLANT INSERTION TORQUE SHOULD NOT EXCEED 70 N-CM; IF 70 N-CM IS REACHED PRIOR TO FULL SEATING, THE IMPLANT SHOULD BE REMOVED AND THE OSTEOTOMY SHOULD BE ENLARGED. CLINICIAN STATED THAT LODI IMPLANTS FAILED TO OSSEOINTEGRATE. THE PATIENT HAS HIGH DENSITY BONE. THE IMPLANTS WERE NOT IMMEDIATELY LOADED. THE CLINICIAN DID NOT PROVIDE THE FOLLOWING INFORMATION: AMOUNT OF TORQUE USED ON ABUTMENT & IMPLANT; 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 WITH 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 DISCREPANCIES OR ISSUES OF NON-CONFORMANCE WERE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF THE PARTS. IMPLANTS WERE MANUFACTURED TO SPECIFICATIONS. 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
    363594 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. I0NKQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention