BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE - 2 IMPLANTS

    MDR report key: 17789753 · Received September 21, 2023

    Report

    Report Number
    3007362683-2023-00038
    Event Type
    Injury
    Date Received
    September 21, 2023
    Date of Event
    September 4, 2023
    Report Date
    November 29, 2023
    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

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR INVESTIGATION. THE INVESTIGATION OF THE DIGITAL SIMPLANT GUIDE DESIGN FILE DID NOT REVEAL ISSUES. THE DESIGN OF THE SIMPLANT GUIDE HAS BEEN PERFORMED CORRECTLY. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Additional Manufacturer Narrative · 0

    THIS CASE IS ABOUT A GUIDED SURGERY FOR 2 IMPLANTS. ONLY 1 WAS IMPLANTED. SURGERY FOR THE SECOND IMPLANT HAS TO BE PLANNED ANEW, SINCE A NEW GUIDE IS NEEDED. AS A CONSEQUENCE OF AN ISSUE EXPERIENCED WITH THE GUIDE SURGERY WAS NOT POSSIBLY TO BE FULLY CONDUCTED AS PLANNED. AN ADDITIONAL, UNPLANNED SURGERY HAS TO BE SCHEDULED. 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. PRODUCT RETURN IS REQUESTED AND PRODUCT WILL BE EVALUATED AFTER RECEIPT. IN CASE ANY NEW OR ADDITIONAL INFORMATION WILL BE GAINED FROM THIS INVESTIGATION A FOLLOW-UP REPORT WILL BE SENT. TREND IS TRACKED AND MONITORED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT SURGIGUIDE - THAT THE SAFE GUIDE BROKE DURING THE OPERATION. WHEN INSERTING NO. 5 AND NO. 6 IN THE UPPER JAW, THE GUIDE BETWEEN NO. 5 AND 6 BROKE WHEN NO. 6 WAS INSERTED AFTER NO. 5 WAS INSERTED. 2023-09-19 KS INFORMATION RECEIVED: SURGERY WAS ONLY POSSIBLE TO BE CONDUCTED FOR POSITION 13, THEN ABORTED AND 14 WILL BE DONE ONCE A NEW GUIDE IS AVAILABLE. NO. 6 OF THE GUIDE BROKE WHEN INSERTING NO. 5 AND NO. 6 IN THE UPPER JAW (FREE END) AFTER NO. 5 WAS INSERTED. (AFTER DRILLING PART 6 WITH THE FIRST DRILL, IT BROKE WHEN BEING PULLED UP, AND THE DRILL SLEEVE WAS STILL ATTACHED TO THE TUBE). THERE IS NO RATTLING IN THE GUIDE, AND DUE TO THIS PRINCIPLE, THERE IS NO LOAD ON THE GUIDE AT POSITION 6 DURING DRILLING. THIS TIME, NO. 5 WAS IMPLANTED, SO AFTER THE PROSTHESIS IS INSTALLED, WE WILL PLACE A GUIDE ORDER AGAIN AND ONLY NO. 6 WILL BE IMPLANTED (THIS IS PUTTING A BURDEN ON THE PATIENT AS THE SURGERY WILL BE PERFORMED TWICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817863 SURGIGUIDE - 2 IMPLANTS ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY SIRONA K.K. DDSC FACTORY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown