BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE TIULTRA RP 5.0X10MM

    MDR report key: 15531779 · Received October 3, 2022

    Report

    Report Number
    2027971-2022-116808
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    September 16, 2022
    Report Date
    October 3, 2022
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747127485
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE IMPLANT MALFUNCTIONED DUE TO DROPPING FROM THE IMPLANT DRIVER. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. USER: (B)(6) RECEIVED DATE OF THE RETURN PRODUCT: 29/09/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589440 NOBELACTIVE TIULTRA RP 5.0X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 300257 12195301 07332747127485

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention