BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 3893894 · Received June 12, 2014

    Report

    Report Number
    2023950-2014-00010
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    USER DOCUMENTATION (TECHNIQUE MANUAL, P/N L8019-TM) 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 30 N-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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLINICIAN: FOUR IMPLANTS WERE PLACED AND WERE IMMEDIATELY LOADED, THREE OF THE FOUR IMPLANTS FAILED TO INTEGRATE. THE CLINICIAN DID NOT SPECIFY THE AMOUNT OF TORQUE USED TO PLACE THE ABUTMENT AND THE IMPLANT. ALSO, THEY DID NOT INDICATE PATIENT'S BONE DENSITY. 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 IMPLANTS' LOT HISTORY RECORDS WERE REVIEWED; 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

    IMPLANTS FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348893 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEIOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC I0L0K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention