BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED EV 4.2 S - 11 MM

    MDR report key: 21732288 · Received March 31, 2025

    Report

    Report Number
    3013111692-2025-10060
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    March 11, 2025
    Report Date
    March 31, 2025
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532132605
    PMA / PMN Number
    K120414
    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. AS PER 21 CFR PART 803, DENTSPLY INC (INCLUDING AFFILIATES) IS CLASSIFIED AS MANUFACTURER/ IMPORTER. AS A RESULT, WE ARE REPORTING THE DENTSPLY SIRONA DEVICE THAT MAY HAVE CONTRIBUTED TO A SERIOUS INJURY.

    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
    912418 OSSEOSPEED EV 4.2 S - 11 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 401170 07392532132605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention