BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5073840 · Received September 10, 2015

    Report

    Report Number
    2023950-2015-00154
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    June 18, 2015
    Report Date
    September 10, 2015
    Manufacturer
    ZEST ANCHORS, INC.
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 TH 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 PLACING THE ABUTMENT, THEY FRACTURED THE IMPLANT. 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/MID-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. REFER TO (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599206 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. I10K8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention