BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACE SELECT TAPERED TIU RP 4.3 X 16MM

    MDR report key: 622602 · Received July 21, 2005

    Report

    Report Number
    2027763-2005-02428
    Event Type
    Injury
    Date Received
    July 21, 2005
    Date of Event
    February 6, 2004
    Report Date
    May 3, 2005
    Manufacturer
    NOBEL BIOCARE USA, LLC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IN 2003 - A DENTAL IMPLANT WAS PLACED IN TOOTH LOCATION #23. SUBSEQUENTLY, THE PT WAS EXPERIENCING SPAIN. IN 2004 - THE IMPLANT WAS REMOVED. IN 06/2005 - THE CLINICIAN WAS CONTACTED. HE STATED "AFTER REMOVAL OF THE IMPLANT THE PT HAS HEALED SATISFACTORY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACE SELECT TAPERED TIU RP 4.3 X 16MM DENTAL IMPLANT DZE NOBEL BIOCARE USA, LLC. * 355112

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention