BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT CLASSICGUIDE

    MDR report key: 18074037 · Received November 6, 2023

    Report

    Report Number
    3006098230-2023-00001
    Event Type
    Injury
    Date Received
    November 6, 2023
    Date of Event
    October 18, 2023
    Report Date
    November 6, 2023
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NANA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MOST LIKELY CAUSE OF THE DEVIATION IS THAT THE GUIDE WAS NOT HELD FIRMLY IN PLACE DURING SURGERY AND CHANGED POSITION WHEN FORCES WERE APPLIED BY THE DRILL.

    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 IMPLANTS AT TOOTH FDI #11, #15, #21, #25 DID NOT END UP AT THE CORRECT POSITION AND ORIENTATION. THEY ENDED UP TOO FAR IN THE DORSAL DIRECTION. AT POSITION #25 THE SINUS FLOOR WAS INJURED. THE DENTIST REMOVED THE IMPLANT #25 AND GRAFTED THE SITE AND WILL LET IT HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131529 SICAT CLASSICGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention CAMLOG GUIDE CA SL P+