BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATGOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 3030577 · Received March 27, 2013

    Report

    Report Number
    2023950-2013-00001
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    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. FURTHERMORE, THE IMPLANT SYSTEM REQUIRES A TORQUE OF AT LEAST 30N-CM. THE IMPLANT THAT FAILED TO INTEGRATE AND THE ONE THAT WAS LOOSE WAS PLACED IN A VERY LOW DENSITY BONE (D3 OR D4). ALSO, CLINICIAN WAS ONLY ABLE TO APPLY A 25N-CM TORQUE ON THE IMPLANT, WHICH IS LESS THAN THE REQUIRED MINIMUM 30N-CM. ALTHOUGH, THE CLINICIAN DID NOT ACHIEVE PRIMARY STABILITY, HE STILL PLACED THE IMPLANTS. THE CLINICIAN REMOVED THE IMPLANTS AND WILL BE REPLACING THEM WITH NEW ONES (THIS TIME ENSURING THAT THE IMPLANT PLACEMENT SPECIFICATIONS ARE FOLLOWED). THE IMPLANT LOT HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES OR ISSUES OF NON-CONFORMANCE WERE NOTED. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ONE IMPLANT FAILED TO INTEGRATE AND ONE WAS LOOSE DUE TO LOW TORQUE (25 N-CM INSTEAD OF MINIMUM 30 N-CM) AND WAS PLACED ON VERY LOW DENSITY BONE D3 OR D4) WHERE PRIMARY STABILITY WAS NOT ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126108 LOCATGOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC 18957, 19350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention