BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL RP 4.3X8.5MM

    MDR report key: 10416398 · Received August 17, 2020

    Report

    Report Number
    9611993-2020-33317
    Event Type
    Injury
    Date Received
    August 17, 2020
    Date of Event
    February 12, 2020
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    7332747017953
    PMA / PMN Number
    K083205
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PMN K083205, LST D080128, PROD CODE 76DZE, DEV 9611993.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877266 NOBELACTIVE INTERNAL RP 4.3X8.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12113286 7332747017953

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention