BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC RP 5.0X8MM

    MDR report key: 17229285 · Received June 29, 2023

    Report

    Report Number
    9611993-2023-082323
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    June 7, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K062566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED. 06/29/2023 19:02:01 CET (5020732) USER:5020732 RECEIVED DATE OF THE RETURN PRODUCT:29/06/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476398 NOBELREPLACE CC RP 5.0X8MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention