BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK IMPL B11 D4,5 MM/L11 MM

    MDR report key: 14840688 · Received June 28, 2022

    Report

    Report Number
    3013111692-2022-11732
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    June 15, 2022
    Report Date
    June 28, 2022
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    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
    1813615 ANK IMPL B11 D4,5 MM/L11 MM SUTURE, DENTAL DZG DENTSPLY IMPLANTS MANUFACTURING GMBH 20003697

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention