BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACE SELECT STRAIGHT TIU WP 5.0X13MM

    MDR report key: 634876 · Received September 8, 2005

    Report

    Report Number
    2027763-2005-11135
    Event Type
    Injury
    Date Received
    September 8, 2005
    Date of Event
    May 13, 2005
    Report Date
    June 27, 2005
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IN 2005, A DENTAL IMPLANT WAS PLACED IN TOOTH LOCATION #30. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING PARESTHESIA AND PAIN. ABOUT FIVE WEEKS LATER THE POST OP X-RAY SHOWED THE IMPLANT ABOVE THE NEUROVASCULAR CANAL. THE PATIENT ELECTED TO HAVE THE IMPLANT REMOVED. IN 08/2005 - THE CLINICIAN WAS CONTACTED. HE STATED THE PATIENT FELT BETTER AND WAS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACE SELECT STRAIGHT TIU WP 5.0X13MM DENTAL IMPLANT DZE NOBEL BIOCARE AB * 650795

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention