BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC PMC RP 4.3X8MM

    MDR report key: 19932436 · Received August 7, 2024

    Report

    Report Number
    9611993-2024-097112
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    August 19, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K073142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534809 NOBELREPLACE CC PMC RP 4.3X8MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention