BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 4274193 · Received November 6, 2014

    Report

    Report Number
    2023950-2014-00015
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    November 5, 2014
    Manufacturer
    ZEST ANCHORS, INC.
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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. THE FOLLOWING INFORMATION WAS NOT PROVIDED BY THE CLINICIAN: WHETHER PRIMARY STABILITY WAS ACHIEVED. THE AMOUNT OF TORQUE USED TO PLACE THE ABUTMENT THE IMPLANT. FAILURE TO OSSEOINTEGRATE IS A WELL-DOCUMENTED INHERENT RISK OF DENTAL IMPLANTS, IN THIS CASE, THE ISSUE MAY HAVE BEEN RELATE TO INADEQUATE PRE-TREATMENT PLANNING, TECHNIQUE AND PATIENT CARE. THE IMPLANTS MAY NOT HAVE ACHIEVED PRIMARY STABILITY AND WERE STILL IMMEDIATELY LOADED. ALSO, THE PAIN EXPERIENCED BY THE PATIENT STRONGLY INDICATES THAT THE IMPLANT WAS PLACED ON OR NEAR A NERVE. SINCE THE PATIENT HAS DOWNS SYNDROME IT IS POSSIBLE THAT THEY MAY NOT HAVE BEEN ABLE TO MAINTAIN ADEQUATE CARE OF THE RESTORATION DURING THE HEALING PROCESS. THE IMPLANTS' LOT HISTORY RECORDS WERE REVIEWED; ANY DISCREPANCIES OR ISSUE OF NON-CONFORMANCE WERE SUCCESSFULLY RESOLVED PRIOR TO THE RELEASE OF THE PARTS. IMPLANTS WERE MANUFACTURED TO SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A MONTH AFTER PLACEMENT, ONE IMPLANT (2) WAS NOTED TO HAVE CLASS 3 MOBILITY (VERY LOOSE) AND THE SECOND IMPLANT CAME OUT WHEN DENTURE WAS REMOVED. THESE WERE CONSIDERED BY THE CLINICIAN AS NON-INTEGRATION ISSUES. ALSO, PATIENT FELT PAIN AT THE IMPLANT SITE WITH THE LOOSE IMPLANT. THE IMPLANTS WERE IMMEDIATELY LOADED. THE PATIENT HAD HIGH DENSITY BONE (TYPE 1) AND ALSO HAD DOWNS SYNDROME. THE TWO IMPLANTS USED WERE AS FOLLOWS: -PN 07462, LOT # I0NZ, MANUF. DATE: 03/2014; EXPIRATION DATE: 02/29/2019. -P/N 07461, LOT #I0R0X, MANUF. DATE: 07/2014; EXPIRATION DATE: 05/31/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713118 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. I0NKZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention