BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOBELPARALLEL CC WP 5.5X8.5MM

    MDR report key: 11910224 · Received May 31, 2021

    Report

    Report Number
    2027971-2021-76322
    Event Type
    Death
    Date Received
    May 31, 2021
    Date of Event
    April 8, 2021
    Report Date
    May 31, 2021
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    7332747091359
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. THE INITIAL REPORT INCLUDED "DEATH" AS ONE OF THE OUTCOMES ATTRIBUTED TO THE ADVERSE EVENT IN SECTION B2 OF THE REPORT. THIS SELECTION WAS MADE IN ERROR. THE CORRECT OUTCOME OF THE ADVERSE EVENT IS "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/ DAMAGE".

    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
    807064 NOBELPARALLEL CC WP 5.5X8.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12166992 7332747091359

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| R