BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT RC INICELL

    MDR report key: 14604457 · Received June 6, 2022

    Report

    Report Number
    3003708589-2022-00086
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    February 25, 2022
    Report Date
    April 9, 2022
    Manufacturer
    THOMMEN MEDICAL AG
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD PAIN AND INFLAMMATION. PATIENT CALLED WITH PAIN, IMPLANT WAS LOOSE. REMOVED AND GBR COMPLETED FOR FUTURE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159641 CONTACT RC INICELL DENTAL IMPLANT DZE THOMMEN MEDICAL AG 4.23.253 22766

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other