BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT CLASSICGUIDE

    MDR report key: 7405788 · Received April 8, 2018

    Report

    Report Number
    3006098230-2018-00003
    Event Type
    Injury
    Date Received
    April 8, 2018
    Date of Event
    December 18, 2017
    Report Date
    April 7, 2018
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVIATION IN VERTICAL IMPLANT POSITION ARE MOST LIKELY DUE TO THE FIT OF THE GUIDE DURING SURGERY NOT BEING IDENTICAL TO THE FIT OF THE RADIOGRAPHIC TEMPLATE DURING X-RAY SCANNING. THIS WAS PROBABLY CAUSED BY ADDING TOO MUCH ACRYLIC WHEN CORRECTING THE RADIOGRAPHIC TEMPLATE IN THE SICAT DENTAL LAB. THE TEMPLATE WAS CORRECTED BY CUTTING AWAY THE BITE REGISTRATION MATERIAL AND REPLACING IT WITH ACRYLIC SUCCESSIVELY. (B)(4).

    Description of Event or Problem · 1

    THE REPORTING DENTIST WANTED TO USE A SICAT SURGICAL GUIDE (SICAT CLASSIC GUIDE) FOR PREPARING THE OSTEOTOMYIES (DRILL HOLE FOR ACCOMMODATING A DENTAL IMPLANT) FOR SIX DENTAL IMPLANTS OF TYPE "DENTSPLY XIVE S PLUS". ON (B)(6) 2017, THE DENTIST PLACED THE IMPLANT USING THE SURGICAL GUIDE AT SITE ADA #14. HE PLACED THE GUIDE IN THE MOUTH AND STARTED WITH PILOT DRILL FOR IMPLANT AT SITE ADA #14. HE CONTINUED THROUGH THE ENTIRE SEQUENCE AND NOTICED IT WAS 2MM SHORT IN DEPTH. HOWEVER, HE DECIDED TO PLACE THE IMPLANT AND ABORT THE REMAINING IMPLANTS. HE DID NOT DO ANY DRILLINGS FOR OTHER IMPLANTS. APPROXIMATELY 3 WEEKS AFTER SURGERY, #14 IMPLANT FAILED AND FELL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248683 SICAT CLASSICGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention