BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT CLASSICGUIDE

    MDR report key: 12116241 · Received July 5, 2021

    Report

    Report Number
    3006098230-2021-00002
    Event Type
    Injury
    Date Received
    July 5, 2021
    Date of Event
    June 3, 2021
    Report Date
    July 5, 2021
    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 FOLLOWING SCENARIO APPEARS TO BE THE MOST PROBABLE: DUE TO THE EXERTION OF TOO STRONG FORCES ONTO THE SLEEVE DURING THE SURGICAL PROCEDURE (DRILLING OR IMPLANT INSERTION) THE POTENTIALLY WEAK ACRYLIC CRACKED, RESULTING IN A LOSS OF STABILITY OF THE OPEN SLEEVE. THE OPEN SLEEVE COULD NOW, WITH ENOUGH TORQUE APPLIED, BE WIDENED LIKE A CLASP, ESPECIALLY SINCE THE COLLAR OF THE OPEN SLEEVE WAS REMOVED PARTLY. THE OPEN SLEEVE COULD NOT GUIDE THE INSTRUMENTS ACCURATELY ANY LONGER.

    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. HOWEVER, THE IMPLANT (TOOTH #19) 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
    1013005 SICAT CLASSICGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention