BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOBELACTIVE INTERNAL NP 3.5X11.5MM

    MDR report key: 15017771 · Received July 14, 2022

    Report

    Report Number
    9611993-2022-077597
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    June 22, 2022
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747160031
    PMA / PMN Number
    K071370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE IMPLANT MALFUNCTIONED DUE TO IT DEFORMING DURING PLACEMENT. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS 14.07.2022 15:52:24 CET (5011055). USER:5011055 RECEIVED DATE OF THE RETURN PRODUCT:14/07/2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557232 NOBELACTIVE INTERNAL NP 3.5X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 34126 12198652 07332747160031

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention