BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE TIULTRA NP 3.5X13MM

    MDR report key: 11909555 · Received May 31, 2021

    Report

    Report Number
    9611993-2021-65274
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    May 18, 2021
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    7332747127386
    PMA / PMN Number
    K202344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PMN K202344, LST D426356, PROD CODE DZE, DEV 9611993.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804749 NOBELACTIVE TIULTRA NP 3.5X13MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12173083 7332747127386

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention