BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOBELACTIVE TIULTRA RP 4.3X11.5MM

    MDR report key: 12732468 · Received November 1, 2021

    Report

    Report Number
    2027971-2021-125203
    Event Type
    Death
    Date Received
    November 1, 2021
    Date of Event
    September 23, 2021
    Report Date
    November 1, 2021
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747127430
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM. THE PRESENT FOLLOW-UP SUBMISSION IS A CORRECTIVE SUBMISSION FOR THE INCORRECT MFG. SUBMISSION/SUBMISSIONS RELATED TO (B)(4). THE CORRECTIVE ACTION HAS BEEN TAKEN UNDER FDA CDRH EMDR [email protected] GUIDANCE. DEATH WAS SELECTED IN ERROR.

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627487 NOBELACTIVE TIULTRA RP 4.3X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 300252 12151745 07332747127430

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death| R