BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL RP 4.3X10MM

    MDR report key: 13954165 · Received March 30, 2022

    Report

    Report Number
    2027971-2022-055941
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    March 17, 2022
    Report Date
    March 30, 2022
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747160062
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. (B)(6) 2022 18:23:23 CET ((B)(4)) USER: (B)(4).RECEIVED DATE OF THE RETURN PRODUCT:29/03/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420782 NOBELACTIVE INTERNAL RP 4.3X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 34131 12171132 07332747160062

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention