BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NPR FCZ IMP CRWN ASC CC WP CAD 0° S4

    MDR report key: 10085447 · Received May 25, 2020

    Report

    Report Number
    2027971-2020-13214
    Event Type
    Injury
    Date Received
    May 25, 2020
    Date of Event
    May 14, 2020
    Report Date
    May 25, 2020
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548959 NPR FCZ IMP CRWN ASC CC WP CAD 0° S4 ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention