BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL RP 4.3X11.5MM

    MDR report key: 19744575 · Received July 15, 2024

    Report

    Report Number
    2027971-2024-101569
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 15, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747160079
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION 15.07.2024 08:05:55 CET (5001035) OSTEOMYELITIS WAS SELECTED AS A CONDITION INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748414 NOBELACTIVE INTERNAL RP 4.3X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12025812 07332747160079

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention