BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT CLASSICGUIDE

    MDR report key: 8094986 · Received November 21, 2018

    Report

    Report Number
    3006098230-2018-00006
    Event Type
    Injury
    Date Received
    November 21, 2018
    Date of Event
    October 26, 2018
    Report Date
    November 21, 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 RELEVANT DRILL SLEEVE WAS PLACED AT INCORRECT POSITION/ANGULATION IN SICAT SURGICAL GUIDES LABORATORY.

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT SURGICAL GUIDE (SICAT CLASSICGUIDE) FOR PREPARING OSTEOTOMIES (DRILL HOLES FOR ACCOMMODATING A DENTAL IMPLANT) FOR DENTAL IMPLANTS OF TYPE ASTRATECH OS EV S. HOWEVER, FOR IMPLANT OF TOOTH #10, THE GUIDE POSITIONED THE OSTEOTOMY ALMOST TOUCHING TOOTH #9. THE DENTIST DIDN'T DELIVER THE IMPLANT. HE JUST GRAFTED THE SITE AND WILL LET IT HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936934 SICAT CLASSICGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention ASTRA TECH IMPLANT SYSTEM EV (SURGICAL KIT)