BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIGUIDE GUIDE

    MDR report key: 4961237 · Received July 29, 2015

    Report

    Report Number
    3007362683-2015-00012
    Event Type
    Injury
    Date Received
    July 29, 2015
    Report Date
    May 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
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INSPECTION REVEALED THAT THE BONE REDUCTION WAS TOO VOLUMINOUS, THUS THE IMPROPER FIT OF THE SURGICAL GUIDE OCCURRED. THEREFORE, BECAUSE TREATMENT COULD NOT BE COMPLETED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE BAD FIT OF THE DRILL GUIDE IS PROBABLY CAUSED BY THE COMPLEXITY OF THE REDUCED AREA. IT WOULD BE UNLIKELY THAT THE BONE EDGE DURING SURGERY WAS OBTAINED IN THE SAME WAY AS THE DIGITAL SIMULATION THEREOF. A REPLACEMENT ORDER AFTER A NEW SCAN WILL BE TAKEN.

    Description of Event or Problem · 1

    IN THIS CASE, A CUSTOMER INTENDED TO PLACE COMPETITOR IMPLANTS (BIOHORIZON) BY USING A SURGIGUIDE, SUBSEQUENTLY AFTER EXTENSIVELY REDUCING THE LOCAL BONE SUPPORTED BY A SIMPLANT REDUCTION GUIDE. HOWEVER, HE WAS NOT ABLE TO SEAT THE DRILL GUIDE PROPERLY, THUS HE ASSUMED THAT THE BONE WAS NOT REDUCED SUFFICIENTLY AND REMOVED MORE BONE MATERIAL FROM THE MANDIBLE. BUT STILL THE DRILL GUIDE DID NOT FIT AS DESIRED AND HE SUSPECTED THAT THE DRILLS WERE NOT ABLE TO GO DEEP ENOUGH INTO THE BONE. HE ASSUMED THAT THE GUIDING TUBES WERE LOCATED TOO HIGH IN THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492363 SURGIGUIDE GUIDE VARIOUS, EBG, LLZ, DZE EBG DENTSPLY IMPLANTS N.V. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention