BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCATOR ABUTMENT

    MDR report key: 8784840 · Received July 12, 2019

    Report

    Report Number
    2023950-2019-00364
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 14, 2019
    Report Date
    September 6, 2019
    Manufacturer
    ZEST ANCHORS, LLC
    Product Code
    NHA
    UDI-DI
    00840481112669
    PMA / PMN Number
    K120198
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DR. (B)(6) PLACED ABUTMENT (B)(6) 2018, PATIENT CAME BACK FIRST WEEK IN (B)(6) 2019 WITH BROKEN /LOST ABUTMENT. HE HAD TO CUT THE PATIENT'S GUM WITH A LASER TO OPEN UP THE SITE TO RETRIEVE THE THREADED PART STUCK IN THE IMPLANT.

    Description of Event or Problem · 1

    DR. (B)(6) PLACED ABUTMENT ON (B)(6) 2018, PATIENT CAME BACK FIRST WEEK IN (B)(6) 2019, WITH BROKEN/LOST ABUTMENT. HE HAD TO CUT THE PATIENT'S GUM WITH A LASER TO OPEN UP THE SITE TO RETRIEVE THE THREADED PART STUCK IN THE IMPLANT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578752 LOCATOR ABUTMENT ENDOSSEOUS DENTAL IMPLANT NHA ZEST ANCHORS, LLC 30506-04 L0HMG 00840481112669

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention