BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELPARALLEL CC TIULTRA NP 3.75X11.5MM

    MDR report key: 19418616 · Received May 29, 2024

    Report

    Report Number
    9611993-2024-076272
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    May 15, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    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 WRONG PART USED. 05/29/2024 20:25:43 CET (USVEAL) PHONE (B)(6). USER:USVEAL RECEIVED DATE OF THE RETURN PRODUCT:29/05/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837408 NOBELPARALLEL CC TIULTRA NP 3.75X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12237138

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention