BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED TX 4.0S - 11 MM

    MDR report key: 11721726 · Received April 24, 2021

    Report

    Report Number
    9612468-2021-04462
    Event Type
    Injury
    Date Received
    April 24, 2021
    Date of Event
    September 12, 2020
    Report Date
    April 24, 2021
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    DZE
    PMA / PMN Number
    K053384
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617802 OSSEOSPEED TX 4.0S - 11 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) NA 450287

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention