BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE - 1 IMPLANT

    MDR report key: 21066159 · Received January 3, 2025

    Report

    Report Number
    3007362683-2025-00001
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    December 4, 2024
    Report Date
    April 30, 2025
    Manufacturer
    DENTSPLY SIRONA K.K. DDSC FACTORY
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DENTAL IMPLANT WAS PLACED USING A SURGIGUIDE IN A POSITION THAT SHIFTED TOWARD THE TONGUE SIDE FROM THE PLANNED POSITION, AND THE IMPLANT WAS REMOVED AND CLOSED WITH GBR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434299 SURGIGUIDE - 1 IMPLANT ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY SIRONA K.K. DDSC FACTORY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention 26-2412 DIAMETER 3.00 MM LENGTH 11.00 MM: XIVE S P