BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELPARALLEL CC TIULTRA RP 4.3X8.5MM

    MDR report key: 15340533 · Received September 1, 2022

    Report

    Report Number
    9611993-2022-091224
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    June 10, 2022
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747127959
    PMA / PMN Number
    K202344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. 01.09.2022 16:59:17 CET (5011737) USER:5011737 RECEIVED DATE OF THE RETURN PRODUCT:01/09/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2808729 NOBELPARALLEL CC TIULTRA RP 4.3X8.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 300303 12154581 07332747127959

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention