BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NPR FCZ IMP CRWN ASC CC WP CAD 0° S4

    MDR report key: 10085470 · Received May 25, 2020

    Report

    Report Number
    9611993-2020-23102
    Event Type
    Injury
    Date Received
    May 25, 2020
    Date of Event
    May 14, 2020
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K132746
    Adverse Event
    Yes
    Report Source
    Manufacturer 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
    549066 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