BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELPARALLEL CC TIULTRA RP 4.3X13MM

    MDR report key: 18175563 · Received November 20, 2023

    Report

    Report Number
    9611993-2023-120438
    Event Type
    Injury
    Date Received
    November 20, 2023
    Date of Event
    November 3, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K202344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION . 20.11.2023 14:22:24 CET (5023852) USER:5023852 RECEIVED DATE OF THE RETURN PRODUCT:20/11/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089357 NOBELPARALLEL CC TIULTRA RP 4.3X13MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention