BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOBELACTIVE INTERNAL RP 5.0X10MM

    MDR report key: 12003436 · Received June 15, 2021

    Report

    Report Number
    2027971-2021-81506
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    June 10, 2021
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    7332747010664
    PMA / PMN Number
    K071370
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT MALFUNCTIONED DUE TO DROPPING FROM THE IMPLANT DRIVER. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899678 NOBELACTIVE INTERNAL RP 5.0X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13111245 7332747010664

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention