BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT CLASSICGUIDE

    MDR report key: 7190242 · Received January 15, 2018

    Report

    Report Number
    3006098230-2018-00001
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    December 19, 2017
    Report Date
    January 15, 2018
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DOES NOT GIVE ANY INDICATION FOR A MALFUNCTION OR FAULT OF THE SICAT CLASSICGUIDE AS MANUFACTURED BY SICAT. THE GUIDE IS REPRESENTING THE DENTISTS PLANNING AND WAS MANUFACTURED ACCORDING TO THE PLANNING AND PRESCRIPTION OF THE DENTIST. HOWEVER, TO MANUFACTURE A SICAT CLASSICGUIDE A 3D X-RAY SCAN IS NEEDED. DURING THIS 3D X-RAY THE PATIENT HAS TO WEAR A RADIOGRAPHIC TEMPLATE (SCAN STENT). THE 3D X-RAY DATA SHOW, THAT THE RADIOGRAPHIC TEMPLATE WAS NOT PLACED IN THE CORRECT POSITION BY THE DENTIST DURING X-RAY SCANNING. IT WAS PROBABLY LIFTED OUT OF THE CORRECT POSITION BY THE CHEEK AND LIP OF THE PATIENT. THUS THE DENTISTS IMPLANT PLANNING HAD BEEN DONE IN REFERENCE TO AN INCORRECT POSITION OF THE SCAN STENT AND THUS IMPLICTLY TO AN INCORRECT POSITION OF THE SURGICAL GUIDE. WHILE, DURING SURGERY THE SURGICAL GUIDE WAS SITTING CORRECTLY IN THE PATIENTS MOUTH.

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT SURGICAL GUIDE (SICAT CLASSICGUIDE) FOR PREPARING THE OSTEOTOMIES (DRILL HOLE FOR ACCOMMODATING A DENTAL IMPLANT) FOR FOUR DENTAL IMPLANTS OF TYPE "KENTEC SER.#(B)(4), LENGTH 8". ON (B)(6) 2017, THE DENTIST PLACED THE IMPLANTS USING THE SURGICAL GUIDE AT SITES FDI 35, 37, 44 & 46. IMPLANT #36, #35, AND #44 IMPLANTATIONS WERE NO PROBLEM AND THE SURGICAL GUIDE FITTED IN PATIENT MOUTH PROPERLY. WHEN THE PATIENT CLAIMED NUMBNESS AND PAIN DURING THIRD DRILLING R8 OF MJ GUIDE FOR IMPLANT AT POSITION FDI 46, THE DENTIST STOPPED DRILLING BEFORE FINAL POSITION. ON POST OP X-RAYS THE BOTTOM OF IMPLANT #46 CROSSES MANDIBULAR CANAL AND DENTIST SUSPECTS THE IMPLANT DAMAGED OR COMPRESSED THE NERVUS ALVEOLARIS INFERIOR. THE IMPLANT AT POSITION #46 WAS SHIFTED TO ORAL SIDE COMPARED TO PLANNING POSITION. ON (B)(6) 2017 THE PATIENT FEELS STILL NUMB AROUND MENTAL FORAMEN AREA BUT THERE IS NO BLEEDING OR ANY CRITICAL CONDITION. THE DENTIST ASKED THE PATIENT IF HE WANTS THE IMPLANT TO BE REMOVED. THE PATIENT SAID IT IS OK TO LEAVE THE IMPLANT UNLESS NUMBNESS GETS WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33903 SICAT CLASSICGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Disability