BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYS (LODI)

    MDR report key: 4369852 · Received December 23, 2014

    Report

    Report Number
    2023950-2014-00036
    Event Type
    Injury
    Date Received
    December 23, 2014
    Report Date
    December 23, 2014
    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

    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 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. CLINICAL STATED THAT A LODI IMPLANT FAILED TO OSSEOINTEGRATE. THE CLINICIAN DID NOT PROVIDE THE FOLLOWING INFO: AMOUNT OF TORQUE USED ON ABUTMENT AND IMPLANT, PT BONE DENSITY, WHETHER PRIMARY STABILITY WAS ACHIEVED, AND WHETHER IMPLANT WAS IMMEDIATELY LOADED. FAILURE TO OSSEOINTEGRATE IS A WELL-DOCUMENTED INHERENT RISK OF ENTAL IMPLANTS. IN THE MAJORITY OF CASES WHERE AN IMPLANT FAILS TO INTEGRATE WITH THE BONE AND IS REJECTED BY THE BODY, THE CAUSE MAY BE UNK. THE IMPLANT'S LOT HISTORY RECORD WAS REVIEWED; ANY DISCREPANCIES OR ISSUES OF NON-CONFORMANCE WERE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF THE PART. IMPLANTS WERE MANUFACTURED TO SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    LODI IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847209 LOCATOR OVERDENTURE IMPLANT SYS (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. I0N2L

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention