BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT CLASSICGUIDE

    MDR report key: 16130897 · Received January 10, 2023

    Report

    Report Number
    3006098230-2022-00001
    Event Type
    Injury
    Date Received
    January 10, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 10, 2023
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA#S-P#NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SCENARIO APPEARS TO BE THE MOST PROBABLE: THE PLANNED IMPLANT POSITION #11(23) DOES NOT SEEM TO BE COMPLETELY SURROUNDED BY BONE AT THE PALATAL AND SEEMS TO BE PLACED IN AN AREA OF OBLIQUE BONE STRUCTURE. THE DRILL PROBABLY SLID AT THE BONE STRUCTURE AND CHANGED THE DRILLING DIRECTION. THIS OCCURED BECAUSE THE DENTIST DID NOT PRESS THE SURGICAL GUIDE SUFFICIENTLY TIGHT ONTO THE TEETH DURING SURGERY.

    Description of Event or Problem · 0

    THE REPORTING DENTIST HAS USED A SICAT SURGICAL GUIDE (SICAT CLASSICGUIDE) FOR PREPARING OSTEOTOMIES (DRILL HOLES FOR ACCOMMODATING A DENTAL IMPLANT) FOR DENTAL IMPLANTS. HOWEVER, THE IMPLANT (TOOTH #11) DID NOT END UP AT THE CORRECT POSITION AND ORIENTATION. THE DENTIST REMOVED THE IMPLANT AND GRAFTED THE SITE AND WILL LET IT HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723575 SICAT CLASSICGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG 10301

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention DENT. IMPL. SWEDEN&MARTINA OUT-LINK2 E2-ZT-330-115.