BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE - 1 IMPLANT

    MDR report key: 17546104 · Received August 14, 2023

    Report

    Report Number
    1222802-2023-00016
    Event Type
    Injury
    Date Received
    August 14, 2023
    Report Date
    August 14, 2023
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 AND PLANNING WAS NOT YET EVALUATED DUE TO UNCLARITY OF THE CASE. IN CASE MORE INFORMATION CAN BE GAINED, A FOLLOW UP WILL BE MADE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT SURGIGUIDE - 1 IMPLANT , FOR THE SURGICAL GUIDE FOR TOOTH #19, THE GUIDE HAD A POOR FIT. DOCTOR WENT AHEAD AND TRIED TO GO THROUGH THE PROGRESSION OF IMPLANT DRILLS. WHEN PLACING THE IMPLANT, IT HAD NO TORQUE AND SPUN IN THE OSTEOTOMY SITE. LIKELY DUE TO THE OSTEOTOMIES NOT BEING IN THE EXACT SAME SITE DUE TO POOR FIT. DOCTOR ABORTED THE SURGERY SINCE HE FELT LIKE THE OSTEOTOMY WAS TOO WIDE, AND GRAFTED THE SITE WITH ALLOGENIC BONE GRAFT. THE CUSTOMER DID NOT CHECK THE FIT BEFORE THE PATIENT WAS SEDATED. HE CUTTED THE GUIDE FOR A GOOD FIT: TO CHECK IF IT WOULD FIT BETTER THE NATURAL DENTITION BETTER. ADDITIONAL INFORMATION REQUESTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40895 SURGIGUIDE - 1 IMPLANT ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS NDP DENTSPLY IH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown REF. 26401 4.8 PS X 8MM IMPLANT WITH THE 4.8MM