BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTS GROUP UNKNOWN

    MDR report key: 20595636 · Received November 3, 2024

    Report

    Report Number
    3013111692-2024-33364
    Event Type
    Injury
    Date Received
    November 3, 2024
    Date of Event
    November 22, 2022
    Report Date
    November 3, 2024
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THIS MDR SUBMISSION IS A LATE SUBMISSION. A CAPA HAS BEEN ISSUED. LATE FRANCE - CAPA-2023-129.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LATE FRANCE - CAPA-2023-129

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175968 IMPLANTS GROUP UNKNOWN IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention