BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT CLASSICGUIDE

    MDR report key: 6452666 · Received April 3, 2017

    Report

    Report Number
    3006098230-2017-00004
    Event Type
    Injury
    Date Received
    April 3, 2017
    Date of Event
    March 14, 2017
    Report Date
    April 3, 2017
    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 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, THE ROCKING OF THE SURGICAL GUIDE CAN BE EXPLAINED BY THE FACT THAT THE X-RAY SCAN, THE SURGICAL GUIDE WAS BASED ON, WAS TAKEN APPROXIMATELY 5 MONTHS BEFORE THE SURGERY. SINCE THEN THE PATIENT'S ANATOMY WAS CHANGED SIGNIFICANTLY BY ADJUSTING THE ANATOMY OF SOME TEETH (FILLINGS, INLAYS OR COMPARABLE). SURGICAL GUIDE 97259 WOULD HAVE FITTED TO THE OLD ANATOMY BUT COULD NOT FIT TO THE NEW ANATOMY. THE RP DRILL KEYS OF THE NOBEL GUIDE KIT COULD BE PLACED INTO THE SLEEVE. THE SITUATION EXPLAINED BY THE DENTIST COULD NOT BE REPRODUCED.

    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 TWO DENTAL IMPLANTS OF TYPE "NOBEL REPLACE TAPERED GROOVY (B)(4) ON (B)(6) 2017. SHE TRIED THE GUIDE IN AND FOUND THAT IT ROCKED BUT SHE FELT IT WAS OKAY TO PROCEED AS LONG AS SHE HELD IT FIRMLY IN PLACE. SHE THEN TRIED THE FIRST NOBEL GUIDE KEY IN BOTH SLEEVES AND FOUND IT DIDN'T FIT FOR EITHER. SHE DECIDED NOT TO USE THE KEYS THEN BUT PROCEEDED USING THE GUIDE FOR THE DRILLINGS, WITHOUT THE KEYS. THE DRILLS WERE USED IN THE GUIDE, KEYLESS FOR THE REMAINDER OF THE SURGERY. THE IMPLANTS WERE PLACED AND SHE DISCOVERED THE POSITIONS WERE NOT ACCORDING TO HOW SHE HAD PLANNED. ON (B)(6) 2017 SHE TOOK A POST-OP CBCT SCAN AND WILL SEND THAT TO SICAT, ALONG WITH THE SURGICAL GUIDE AND MODEL FOR EVALUATION. THERE WERE SIGNS OF SLIGHT INFECTION IN THE POST-OP EXAM. IMPLANT AT POSITION ADA 19 FELL OUT ON (B)(6) 2017. THE PATIENT DID NOT SWALLOW IT AND IS DOING OKAY. THE DENTIST WILL BE SENDING THE FAILED IMPLANT TO NOBEL FOR PATHOLOGY ANALYSIS. AS OF (B)(6) 2017 IMPLANT AT POSITION ADA 30 IS MOBILE. SHE DELIVERED TOPICAL ANTIBIOTICS TO THE SITE AND WILL EVALUATE AGAIN, BUT WILL MOST LIKELY REMOVE THIS IMPLANT, AS SHE BELIEVES IT IS ALSO A FAILURE. THE DENTIST HAS TO BONE GRAFT THE AREAS OF THE FAILED IMPLANTS. THE DENTIST WILL ALLOW HEALING FOR SEVERAL MONTHS BEFORE ATTEMPTING TO PLACE ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235793 SICAT CLASSICGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention IMPLANT NOBELREPLACE TAPERED GROOVY (B)(4)