BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE TIULTRA RP 5.0X10MM

    MDR report key: 15521139 · Received September 30, 2022

    Report

    Report Number
    9611993-2022-098139
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    September 15, 2022
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747127485
    PMA / PMN Number
    K202344
    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 DUE TO FAILURE OF OSSEOINTEGRATION. (B)(6) 2022 16:41:25 CET (5010923). USER:(B)(6) RECEIVED DATE OF THE RETURN PRODUCT: (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185741 NOBELACTIVE TIULTRA RP 5.0X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 300257 12193315 07332747127485

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention