BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOBELREPLACE CC RP 4.3X10MM

    MDR report key: 11040652 · Received December 18, 2020

    Report

    Report Number
    2027971-2020-60874
    Event Type
    Death
    Date Received
    December 18, 2020
    Date of Event
    November 23, 2020
    Report Date
    December 18, 2020
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    7332747035711
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503023 NOBELREPLACE CC RP 4.3X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12161177 7332747035711

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| R