BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5017339 · Received August 18, 2015

    Report

    Report Number
    2023950-2015-00134
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    July 17, 2015
    Report Date
    August 18, 2015
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    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 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. WHEN CLINICIAN WAS TORQUING THE ABUTMENT (30 N-CM), THE UPPER PART OF THE IMPLANT BROKE OFF. IN-HOUSE TESTING HAS INDICATED THAT A MINIMUM TORQUE OF 85 NCM ON THE ABUTMENT IS REQUIRED TO CAUSE IMPLANT FAILURE. THEREFORE, IT IS HIGHLY LIKELY THAT THIS INCIDENT MAY HAVE OCCURRED AS A RESULT OF USER ERROR/MIS-USE. THE RECORDS MANAGEMENT DATABASE INDICATES THAT THE IMPLANTS MET THE SPECIFICATIONS AND WERE APPROVED FOR PRODUCT RELEASE. ANY DISCREPANCIES OR ISSUES OF NON-CONFORMANCES WERE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF THE IMPLANTS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    LODI IMPLANT BROKE DURING PLACEMENT. INCIDENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543814 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC I0ZNX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention