BEUDAMED
    FDA Adverse Event Other Summary report: N

    O BUTMENT

    MDR report key: 148592 · Received February 10, 1998

    Report

    Report Number
    1627417-1998-00002
    Event Type
    Other
    Date Received
    February 10, 1998
    Date of Event
    January 15, 1998
    Report Date
    February 6, 1998
    Manufacturer
    "O" CO., INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    FOUR OF THE FIVE IMPLANTS PLACED IN THE MANDIBLE SYMPHYSIS AREA FAILED. THESE IMPLANTS HAD BEEN PLACED 12/23/92. THERE WAS AN EXCESSIVE AMOUNT OF BONE LOSS IN THE AREA THE IMPLANTS WERE LOST. JUDGING FROM THE X-RAYS, THE IMPLANTS PLACED, APPEAR TO BE TOO LONG. THE LINGUAL PLATE OF THE CORTICAL BONE AND LOWER BORDER OF THE MANDIBLE APPEAR TO HAVE BEEN PENETRATED EXPOSING THE HA COATING TO SOFT TISSUE. THIS WOULD SET UP AN INFLAMMATORY RESPONSE WITH ACCOMPANYING ACIDITY WHICH WOULD BREAK DOWN THE HA COATING OF THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O BUTMENT Implant DENTAL IMPLANT DZE "O" CO., INC. 4012 1758

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other