BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED TX 3.5S - 13 MM

    MDR report key: 17594559 · Received August 22, 2023

    Report

    Report Number
    3013111692-2023-53267
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    February 5, 2021
    Report Date
    August 22, 2023
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532108389
    PMA / PMN Number
    K053384
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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.

    Description of Event or Problem · 0

    (B)(6), ¿ REFERENCE CASE (B)(4). ¿ CAPA-2023-143. (B)(4). IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341081 OSSEOSPEED TX 3.5S - 13 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 423622 07392532108389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown