BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5086414 · Received September 16, 2015

    Report

    Report Number
    2023950-2015-00156
    Event Type
    Injury
    Date Received
    September 16, 2015
    Report Date
    September 16, 2015
    Manufacturer
    ZEST ANCHORS, INC.
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICIAN FRACTURED THE IMPLANT UPON PLACEMENT. 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 SUCCESSFUL,LY 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 AT THE APEX DURING PLACEMENT OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611127 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. IORR2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention