BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5210307 · Received November 4, 2015

    Report

    Report Number
    2023950-2015-00204
    Event Type
    Injury
    Date Received
    November 4, 2015
    Date of Event
    October 1, 2015
    Report Date
    November 4, 2015
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 AN D THE OSTEOTOMY SHOULD BE ENLARGED. CLINICIAN STATED THAT LODI IMPLANT FAILED TO OSSEOINTEGRATE. PATIENT HAS MODERATE DENSITY BONE AND DIABETES. THE IMPLANTS WERE NOT IMMEDIATELY LOADED. THE CLINICIAN DID NOT PROVIDE THE FOLLOWING INFORMATION: AMOUNT OF TORQUE USED ON ABUTMENT AND IMPLANT; WHETHER PRIMARY STABILITY WAS ACHIEVED. 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; ANY DISCREPANCIES OR ISSUES OF NON-CONFORMANCES WERE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF THE PARTS. IMPLANT WAS MANUFACTURED TO SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED. REFER TO PER 15-1083.

    Description of Event or Problem · 1

    LODI IMPLANTS FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732948 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC I0MFU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention