BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED TX 3.5S - 11 MM

    MDR report key: 22301255 · Received June 20, 2025

    Report

    Report Number
    3013111692-2025-15727
    Event Type
    Injury
    Date Received
    June 20, 2025
    Report Date
    August 18, 2025
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532108372
    PMA / PMN Number
    K053384
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. SECTION H6 WAS DONE BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND OUR LONG-TIME EXPERIENCE IN THE INVESTIGATION OF SIMILAR COMPLAINTS. PRODUCT RETURN AND ADDITIONAL INFORMATION IS REQUESTED AND PRODUCT WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

    Additional Manufacturer Narrative · 0

    UPDATED THE FOLLOWING ADDITIONAL INFORMATION: LOT: 467721. IMPLANTED DATE: (B)(6) 2022. EXPLANTED DATE: (B)(6) 2025. B5- IMPLANT WAS REMOVED AFTER FRACTURE WAS RECOGNIZED BY THE CUSTOMER AND REPORTED TO DS). PATIENT IS SMOKER. UPDATED H6- CONCLUSIONS CODE 50.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS (FRACTURE). PRODUCT PENDING.

    Description of Event or Problem · 0

    IMPLANT WAS REMOVED AFTER FRACTURE WAS RECOGNIZED BY THE CUSTOMER AND REPORTED TO DS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670676 OSSEOSPEED TX 3.5S - 11 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 467721 07392532108372

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ATLANTIS 0014020367