BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBUTMENT

    MDR report key: 500855 · Received December 5, 2003

    Report

    Report Number
    1627417-2003-00002
    Event Type
    Injury
    Date Received
    December 5, 2003
    Date of Event
    October 31, 2003
    Report Date
    December 2, 2003
    Manufacturer
    "O" CO., INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PROBLEM DETECTED IN 2003, PAIN & INFECTION. EXTRACTED IMPLANT AND GRAFTED BONE, UPPER LEFT #9. IMPLANT LOADED 4 UNIT BRIDGE. BONE LOSS LISTED 3-1/2 CUBIC CM. INFECTION TREATED WITH AMOXICILIN 500MG. PT. TREATED AT HOSPITAL 2 DAYS LATER WITH MORPHINE & ANTIBIOTIC DRIP. (IV).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBUTMENT DENTAL IMPLANT DZE "O" CO., INC. NA 1886

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R