BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT CLASSICGUIDE

    MDR report key: 12266591 · Received August 3, 2021

    Report

    Report Number
    3006098230-2021-00003
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    June 25, 2021
    Report Date
    August 3, 2021
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SCENARIO APPEARS TO BE THE MOST PROBABLE: THE DENTIST PLANNED IMPLANT AT TOOTH #21 IN A WAY, SO THAT AFTER SURGERY THE IMPLANT ENDS UP VERY CLOSE TO THE NERVE CANAL OF THE NERVUS MANDIBULARIS. THIS MAY HAVE CAUSED THE NERVE TO BE COMPRESSED, RESULTING IN THE PARESTHESIA.

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT SURGICAL GUIDE (SICAT CLASSICGUIDE) FOR PREPARING OSTEOTOMIES (DRILL HOLES FOR ACCOMMODATING DENTAL IMPLANTS) FOR DENTAL IMPLANTS. HOWEVER, THE IMPLANTS AT POSITION #21 AND #28 DID NOT END UP AT PRECISELY THE CORRECT POSITON. THE PATIENT EXPERIENCED PARESTHESIA. THE IMPLANT AT POSITION #21 HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167879 SICAT CLASSICGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention BIOMET 3I(IFNT) DENTAL IMPLANT, SN: (B)(4).