BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOBELACTIVE INTERNAL RP 5.0X11.5MM

    MDR report key: 10381765 · Received August 7, 2020

    Report

    Report Number
    2027971-2020-26125
    Event Type
    Death
    Date Received
    August 7, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 7, 2020
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843982 NOBELACTIVE INTERNAL RP 5.0X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| R