BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL RP 4.3X10MM

    MDR report key: 10504154 · Received September 8, 2020

    Report

    Report Number
    2027971-2020-33484
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    August 14, 2020
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    7332747010626
    PMA / PMN Number
    K071370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PMN K071370, LST D080086, PROD CODE 76DZE, DEV 9611993.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969498 NOBELACTIVE INTERNAL RP 4.3X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13086351 7332747010626

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention