BEUDAMED
    FDA Adverse Event Death Summary report: N

    REPLACE SELECT TC NP 3.5X(15+3)MM

    MDR report key: 10410383 · Received August 14, 2020

    Report

    Report Number
    2027971-2020-27728
    Event Type
    Death
    Date Received
    August 14, 2020
    Date of Event
    May 27, 2020
    Report Date
    August 14, 2020
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872263 REPLACE SELECT TC NP 3.5X(15+3)MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R