BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)

    MDR report key: 5073830 · Received September 10, 2015

    Report

    Report Number
    2023950-2015-00148
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    June 1, 2015
    Report Date
    September 10, 2015
    Manufacturer
    ZEST ANCHORS, INC.
    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

    THE IMPLANT WAS REMOVED AND THE SITE WAS GRAFTED. THE PT HAD MODERATE DENSITY BONE AND 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. INFECTION, PAIN, AND SWELLING CAN SOMETIMES OCCUR DURING THE HEALING PERIOD. PT IS NORMALLY TREATED WITH ANTIBIOTICS AND THE IMPLANT SITE IS ALLOWED TO HEAL. BUT, IN THIS CASE, THE CLINICIAN HAD REMOVED THE IMPLANT AND THEN GRAFTED THE EXTRACTION SITE. SINCE THE CLINICIAN HAD TO REMOVE THE IMPLANT, THERE IS A POTENTIAL THAT THE PT WILL REQUIRE ADDITIONAL SURGICAL INTERVENTION (AT A LATER DATE) TO PLACE A NEW IMPLANT. THE RECORDS MANAGEMENT DATABASE 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.

    Description of Event or Problem · 1

    LODI IMPLANT WAS REMOVED DUE TO PAIN, SWELLING, AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599649 LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI) ENDOSSEOUS DENTAL IMPLANT DZE ZEST ANCHORS, INC. 24170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention