BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5073832 · Received September 10, 2015

    Report

    Report Number
    2023950-2015-00151
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    May 12, 2015
    Report Date
    September 10, 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, AND THE IMPLANT SHOULD BE REMOVED AND THE OSTEOTOMY SHOULD BE ENLARGED. CLINICIAN STATED THAT LODI IMPLANT FAILED TO OSSEOINTEGRATE. PT HAS LOW DENSITY BONE AND OSTEOPOROSIS. THE IMPLANTS WERE NOT IMMEDIATELY LOADED. THE CLINICIAN DID NOT PROVIDE THE FOLLOWING INFO: 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 UNK. SINCE THE LOT NUMBER PROVIDED BY THE DISTRIBUTOR WAS INCORRECT, ZEST WAS UNABLE TO REVIEW THE SPECIFIC LHR RECORDS. HOWEVER, ALL ZEST PRODUCTS THAT ARE SHIPPED OUT MUST MEET THEIR SPECIFIC PRODUCT SPECIFICATIONS AND MUST BE APPROVED FOR PRODUCT RELEASED. ANY ISSUES ARE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF ALL PARTS. NO FURTHER ACTION IS REQUIRED. REFER TO (B)(4).

    Description of Event or Problem · 1

    LODI IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599651 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC WRONG # PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention