BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL RP 4.3X11.5MM

    MDR report key: 18974146 · Received March 25, 2024

    Report

    Report Number
    9611993-2024-055923
    Event Type
    Injury
    Date Received
    March 25, 2024
    Date of Event
    January 2, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747010633
    PMA / PMN Number
    K071370
    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 LOSS OF OSSEOINTEGRATION. (B)(6) 2024 11:42:58 CET (5001090). REFERENCE NUMBER FROM FDA: MW5152110.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27773 NOBELACTIVE INTERNAL RP 4.3X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 788080 07332747010633

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention