BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED TX 4.5 - 11 MM

    MDR report key: 11881217 · Received May 25, 2021

    Report

    Report Number
    9612468-2021-28099
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    March 12, 2020
    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
    GA, US
    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
    772750 OSSEOSPEED TX 4.5 - 11 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention