BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE - 5 IMPLANTS

    MDR report key: 22649746 · Received July 29, 2025

    Report

    Report Number
    3007362683-2025-00012
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 29, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. INVESTIGATION RESULTS: THE DHR REVIEW SHOWS CUSTOMER'S ORDER AS A MUCOSA SUPPORTED GUIDE FOR 5 IMPLANT POSITIONS AND 3 FIXATION SCREWS. CUSTOMER'S PLANNING WAS UPLOADED FOR DESIGN BY DS. DURING DESIGN THE CUSTOMER HAS BEEN INFORMED PER ORDER REMARKS ABOUT SEVERAL ISSUES AS THE DRILL TIP OF 46 IS VERY CLOSE TO THE NERVE AND TIP OF 36 IS CLOSE TO THE NERVE; AIR IS VISIBLE BETWEEN THE PROSTHESIS AND SOFT TISSUE AND ARTIFACTS, POSITION WAS OPTIMIZED. THE INVESTIGATION OF THE DIGITAL FILES SHOWS THAT THE POSITION OF THE PROSTHESIS IS OPTIMIZED BY THE DESIGN TEAM, IT ALIGNS BETTER WITH THE SOFT TISSUE COMPARED TO THE PROSTHESIS IMPORTED BY THE CUSTOMER. THE DESIGN OF THE GUIDE IS CORRECT. DURING DESIGN THE GUIDE SLEEVES OF POSITIONS # 46 AND 36 WARE CHANGED FROM OPEN TO CLOSED. THIS HAS NO IMPACT ON THE COMPLAINT INFORMATION AS THE GUIDE DESIGN WAS PERFORMED AS A MUCOSA SUPPORTED GUIDE. CUSTOMER'S APPROVAL IS NEEDED WHEN A DESIGN CHANGE HAS BEEN PERFORMED, NOT ACCORDING TO CUSTOMER'S ORDER. IT'S NOT RELEVANT FOR THIS COMPLAINT AS DESCRIBED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT THE CUSTOMER HAD THOUGHT THEY ORDERED A GUIDE WITH BONE SUPPORT BUT THE GUIDE ARRIVED WITH MUCOSAL SUPPORT. THIS WAS REALIZED AFTER OPENING THE FLAP. REQUESTED DEVICE TO BE REPRODUCED WITH CORRECT SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861414 SURGIGUIDE - 5 IMPLANTS ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY SIRONA K.K. DDSC FACTORY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention