BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 3868301 · Received April 23, 2014

    Report

    Report Number
    2023950-2014-00007
    Event Type
    Injury
    Date Received
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    DZE
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ONE WEEK AFTER IMPLANT PLACEMENT (PRIOR TO THE OSSEOINTEGRATION OF THE IMPLANT), THE CLINICIAN DECIDED TO USE A DIFFERENT ABUTMENT (CHANGE CUFF HEIGHT). THEY PROCEEDED TO REMOVE THE TORQUED ABUTMENTS AND INADVERTENTLY EXTRACTED THE NON-INTEGRATED IMPLANTS. SO, THE PT WILL REQUIRE ADD'L SURGICAL INTERVENTION TO REPLACE THE IMPLANTS THAT WERE TAKEN OUT. AS INTENDED, TORQUING AN ABUTMENT PERMANENTLY SECURES IT ON TO THE IMPLANT. THEREFORE, IN ORDER TO REMOVE THE TORQUED ABUTMENT, THE CLINICIAN WOULD HAVE TO APPLY A REVERSE-TORQUE, WHICH WOULD ALSO EXTRACT THE IMPLANT IF IT HAS NOT YET BEEN INTEGRATED INTO THE BONE. THE LODI USER DOCUMENTATION (L8019-TM) INCLUDES INFO ON PRE-SURGICAL TREATMENT PLANNING. THE CLINICIAN IS INSTRUCTED TO MEASURE THE GINGIVA DEPTH AT EACH IMPLANT DEPTH PRIOR TO IMPLANT PLACEMENT TO PROPERLY SELECT THE ABUTMENT CUFF HEIGHT. BASED ON THE ABOVE, IT WAS CONCLUDED THAT THIS EVENT OCCURRED AS A RESULT OF THE CLINICIAN'S MISUSE OF THE DEVICE (USER ERROR). THE LOT HISTORY RECORDS OF EACH OF THE IMPLANTS WERE REVIEWED AND NO DISCREPANCIES OR ISSUES OF NON-CONFORMANCE WERE NOTED. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CLINICIAN DECIDED TO CHANGE THE ABUTMENTS ONE WEEK AFTER IMPLANT PLACEMENT (BEFORE OSSEOINTEGRATION OF THE IMPLANT HAS OCCURRED) AND INADVERTENTLY EXTRACTED THE IMPLANTS. THE THREE IMPLANTS EXPIRATION DATE AND MANUFACTURING DATE ARE AS FOLLOWS: LOT #: I0KGN, CATALOG #: 07462, MFG DATE: 11/22/2013, EXP DATE: 10/31/2018. LOT #: I0N2H, CATALOG #: 07461, MFG DATE: 03/05/2014, EXP DATE: 01/31/2019. LOT #: I0MXK, CATALOG #: 07460, MFG DATE: 03/05/2014, EXP DATE: 01/31/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245890 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, LLC I0MXK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention