BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 6113793 · Received November 18, 2016

    Report

    Report Number
    2023950-2016-00167
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    May 6, 2016
    Report Date
    August 25, 2016
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    USER DOCUMENTATION (TECHNIQUE MANUAL, PN 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. CLINICIAN STATED THAT A LODI IMPLANT FAILED TO OSSEOINTEGRATE. PATIENT HAS LOW DENSITY BONE. IMPLANT WAS NOT IMMEDIATELY LOADED. THE CLINICIAN DID NOT PROVIDE THE FOLLOWING INFORMATION: AMOUNT OF TORQUE USED ON ABUTMENT & 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 RECORDS MANAGEMENT DATABASE OF EACH OF THE ORDERED IMPLANTS INDICATES THAT THE IMPLANTS MET THE SPECIFICATIONS AND WERE APPROVED FOR PRODUCT RELEASE. ANY ISSUES WERE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF THE IMPLANTS. NO FURTHER ACTION IS REQUIRED. REFER TO PER (B)(4).

    Description of Event or Problem · 1

    LODI IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762860 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC 07455 I10K0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention