BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELSPEEDY GROOVY RP 4X10MM

    MDR report key: 16977648 · Received May 22, 2023

    Report

    Report Number
    9611993-2023-069124
    Event Type
    Injury
    Date Received
    May 22, 2023
    Date of Event
    May 15, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747159820
    PMA / PMN Number
    K050406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. (B)(6) 2023. 10:37:29 CET ((B)(6)). USER: (B)(6) RECEIVED DATE OF THE RETURN PRODUCT: (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493460 NOBELSPEEDY GROOVY RP 4X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 32148 12202782 07332747159820

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention