BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE GUIDE

    MDR report key: 4961253 · Received July 29, 2015

    Report

    Report Number
    3007362683-2015-00011
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    April 22, 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
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE DENTIST CHANGED THE FINAL DESIGN OF THE GUIDE ON THE CAST MODEL TO MODIFY THE POSITION OF THE PLANNED IMPLANT IN REGION 34. IN ADDITION, IT IS STATED THAT HE DID NOT USE THE DRILLS AS ADVISED TO ENLARGE THE APICAL PART OF THE OSTEOTOMY, IN ORDER TO ADAPT THE DESIGN OF THE SITE TO THE LOCAL BONE QUALITY: IN THE MANDIBLE USUALLY THE PREDOMINANT BONE QUALITY IS OF DENSE TYPE, THUS THE ENLARGEMENT OF THE PREPARED BONE IS REQUIRED TO LIMIT THE INSERTION TORQUE TO SUFFICIENT VALUES. THE FACT THAT THE IMPLANTS WERE NOT PLACED INTO THE FINAL POSITION, E.G. AS DEEP AS INTENDED, SEEMS TO BE A SIGN FOR AN INCOMPLETE PREPARATION OF THE IMPLANT SITE. THEREFORE, BECAUSE SURGERY COULD NOT BE COMPLETED AS INTENDED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. IT'S CLEAR THE CHANGES IN THE MOUTH AFTER IMPRESSION WAS MADE CAUSED THE BAD FIT AND THE BAD TRANSFER. THE DENTIST REALIZED AND CORRECTED HIS OWN MISTAKE AND WAS ABLE TO COMPLETE THE SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGIGUIDE WAS USED TO PLACE FOUR IMPLANTS (REGIONS NOT INDICATED). THE IMPLANTS WERE PLACED TOO SHALLOW AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492364 SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE EBG DENTSPLY IMPLANTS N.V. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention