BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOSPEED TX 4.0S - 13 MM

    MDR report key: 18677464 · Received February 9, 2024

    Report

    Report Number
    3013111692-2024-04201
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    April 25, 2023
    Report Date
    February 26, 2024
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    UDI-DI
    07392532108327
    PMA / PMN Number
    K053384
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    Additional Manufacturer Narrative · 0

    FDA CODING WAS MISSED IN THE INITIAL REPORT. ADDING ADDITIONAL HEALTH EFFECT- CLINICAL CODE 2013. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. FDA CODING WAS MISSED IN THE INITIAL REPORT. ADDING ADDITIONAL INVESTIGATION CONCLUSIONS CODE 50. THIS IS A FOLLOW UP REPORT TO ADD THIS ADDITIONAL CODE. CORRECTING LOT # FROM 1223826 TO 122362. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION.

    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
    82506 OSSEOSPEED TX 4.0S - 13 MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 122362 07392532108327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention