BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOBELACTIVE TIULTRA 3.0 3.0X10MM

    MDR report key: 15539068 · Received October 4, 2022

    Report

    Report Number
    2027971-2022-117360
    Event Type
    Death
    Date Received
    October 4, 2022
    Date of Event
    September 19, 2022
    Report Date
    October 4, 2022
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747127317
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION. THE INITIAL REPORT DID NOT HAVE THE CORRECT OUTCOMES ATTRIBUTED TO ADVERSE EVENT - DEATH, THE CORRECT ONE - REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)IS PROVIDED IN THIS FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2388069 NOBELACTIVE TIULTRA 3.0 3.0X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 300240 12198647 07332747127317

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| D