BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELPARALLEL CC TIULTRA NP 3.75X18MM

    MDR report key: 17437403 · Received August 1, 2023

    Report

    Report Number
    9611993-2023-092078
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 6, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K202344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. (B)(6) 2023 16:45:57 CET (5021118). USER:5021118 RECEIVED DATE OF THE RETURN PRODUCT: (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842972 NOBELPARALLEL CC TIULTRA NP 3.75X18MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention