BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBUTMENT

    MDR report key: 500858 · Received December 5, 2003

    Report

    Report Number
    1627417-2003-00001
    Event Type
    Injury
    Date Received
    December 5, 2003
    Date of Event
    September 16, 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
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT. IN FOR PAIN ONE WEEK PRIOR TO EXTRACTION. EXTRACTED BLADE IMPLANT UPPER RIGHT. IMPLANT LOADED TEMPORARY 3 UNIT BRIDGE. NO GRAFTING MATERIAL USED. SINUS FLOOR PERFORATED. BONE LOSS 3-4 CUBIC CM. INFECTION WAS DEBRIDED, PT, ON ANTIBIOTICS. PT. ON RECALL 6MOS. TO A YEAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention