BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ATIS ABUTMENT

    MDR report key: 15759055 · Received November 9, 2022

    Report

    Report Number
    3013111692-2022-23349
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    January 17, 2022
    Report Date
    November 9, 2022
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND OUR LONG-TIME EXPERIENCE IN THE INVESTIGATION OF SIMILAR COMPLAINTS. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. TREND IS TRACKED AND MONITORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2953093 UNKNOWN ATIS ABUTMENT SUTURE, DENTAL DZG DENTSPLY IMPLANTS MANUFACTURING GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention 24932 LOT187627