BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC TIULTRA NP 3.5X11.5MM

    MDR report key: 13969586 · Received March 31, 2022

    Report

    Report Number
    9611993-2022-051806
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    March 17, 2022
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747128307
    PMA / PMN Number
    K202344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM (B)(6) 2022 08:21:11 CET ( (B)(6)) PHONE (B)(6). IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105414 NOBELREPLACE CC TIULTRA NP 3.5X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 300339 12192048 07332747128307

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention