BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELPARALLEL CC TIULTRA RP 5.0X18MM

    MDR report key: 17702785 · Received September 7, 2023

    Report

    Report Number
    9611993-2023-101129
    Event Type
    Injury
    Date Received
    September 7, 2023
    Date of Event
    September 5, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747128086
    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. (B)(6) 2023 14:24:13 CET (5010400). USER:5010400 RECEIVED DATE OF THE RETURN PRODUCT: (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926129 NOBELPARALLEL CC TIULTRA RP 5.0X18MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12201013 07332747128086

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention