BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 3767364 · Received April 3, 2014

    Report

    Report Number
    2023950-2014-00006
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    October 15, 2013
    Report Date
    April 3, 2014
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 70N-CM; IF 70N-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: IMPLANT WAS NOT IMMEDIATELY LOADED IMPLANTS. IMPLANT WAS NOT RESTORED. IMPLANT THAT DID NOT INTEGRATE WAS PLACED IN TOOTH POSITION 33. IMPLANT WAS NOT PLACED INTO AN IMMEDIATE EXTRACTION SITE. PT FELT PAIN IN THE AREA OF TOOTH #33. ALL REMAINING IMPLANTS WERE OSSEO-INTEGRATED. THE CLINICIAN DID NOT SPECIFY THE AMOUNT OF TORQUE USED TO PLACE THE IMPLANT AND TORQUE THE ABUTMENT. THEY DID NOT INDICATE THE PT'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 IMPLANT'S LOT HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES OR ISSUES OF NON-CONFORMANCE WERE NOTED. IMPLANT WAS MANUFACTURED TO SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203281 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC 21127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention