BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOBELREPLACE CC PMC NP 3.5X13MM

    MDR report key: 15159056 · Received August 3, 2022

    Report

    Report Number
    2027971-2022-097010
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 7, 2022
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    07332747160680
    PMA / PMN Number
    K073142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. (B)(6) 2022 18:35:50 CET (GBSAKH) PHONE: (B)(6). USER:GBSAKH RECEIVED DATE OF THE RETURN PRODUCT:(B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064414 NOBELREPLACE CC PMC NP 3.5X13MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 37288 13127856 07332747160680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention