BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE GUIDE

    MDR report key: 4961251 · Received July 29, 2015

    Report

    Report Number
    3007362683-2015-00009
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    March 25, 2015
    Manufacturer
    DENTSPLY IMPLANTS N.V.
    Product Code
    EBG
    PMA / PMN Number
    K113739
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE AN INTERVENTION WAS REQUIRED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A SURGIGUIDE TO PLACE THREE IMPLANTS, THE MODEL INITIALLY SAT FINE IN THE PATIENT'S MOUTH. AT THE HALFWAY POINT OF DRILLING TO PLACE IMPLANT (B)(4), THE GUIDE BEGAN TO ROCK AND THE DOCTOR THOUGHT THAT IT WAS BENT. AT THIS POINT IMPLANT (B)(4) WAS PARTIALLY PLACED. THE DOCTOR TREPHINED OUT IMPLANT (B)(4) BECAUSE THE IMPLANT WASN'T IN THE PLANNED POSITION. THE GUIDE WAS REMOVED AND IMPLANT (B)(4) WAS NOT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492511 SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE EBG DENTSPLY IMPLANTS N.V. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention