BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT OPTIGUIDE

    MDR report key: 5609601 · Received April 26, 2016

    Report

    Report Number
    3006098230-2016-00001
    Event Type
    Injury
    Date Received
    April 26, 2016
    Date of Event
    March 30, 2016
    Report Date
    March 30, 2016
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTIST SUSPECTED THAT THE SURGICAL GUIDE WAS NOT MANUFACTURED ACCORDING TO HER PRESCRIPTION/PLANNING. THE DENTIST HAD RETURNED THE SUSPECTED DENTAL GUIDE BACK TO SICAT FOR EVALUATION. BEFORE INITIAL SHIPMENT OF THE GUIDE TO THE DOCTOR, THE SLEEVE POSITION HAD BEEN VERIFIED AT SICAT SURGICAL GUIDES LAB USING A COORDINATE MEASUREMENT MACHINE. THE FINAL PROTOCOL OF THIS PROCEDURE HAS BEEN REEVALUATED. THE PROTOCOL DOES NOT SHOW ANY RELEVANT DEVIATION OF THE ACTUAL SLEEVE POSITION AND ANGULATION COMPARED TO THE DOCTORS PLANNING OF SLEEVE POSITION AND ANGULATION. THE RETURNED SURGICAL GUIDE WAS EVALUATED USING OPTICAL SCANS AND X-RAY SCANS OF THE SURGICAL GUIDE AND A PLASTER MODEL OF THE PATIENTS JAW. NEITHER AN EXACT QUANTITATIVE ANALYSIS NOR THE OVERLAYS OF OPTICAL SCANS AND X-RAY SCANS GIVE AN INDICATION FOR AN INCORRECT PLACEMENT OF THE SLEEVE COMPARED TO THE DOCTORS PLANNING. THE DEVICE HAS BEEN RETURNED TO THE REPORTING DENTIST AGAIN TOGETHER WITH A SUMMARY OF THE EVALUATION RESULTS. THE DENTIST CLAIMS THAT SHE HAS OPTICAL SCANS OF THE SURGICAL GUIDE DIRECTLY AFTER (OR BEFORE) SURGERY. SHE SAYS THOSE SCANS DO PROVE THAT THE ANGLE OF THE SLEEVE WITHIN THE GUIDE IS NOT CORRECT. SHE IS NOT WILLING TO PROVIDE THOSE OPTICAL SCANS FOR ANALYSIS.

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT SURGICAL GUIDE (SICAT OPTIGUIDE) FOR PREPARING THE OSTEOTOMY (DRILL HOLE FOR ACCOMMODATING THE DENTAL IMPLANT) FOR A HIOSSEN DENTAL IMPLANT. THE REPORTING DENTIST WAS VERY PLEASED WITH THE FIT OF THE SICAT OPTIGUIDE MADE BY SICAT FOR THE PATIENT. RETENTION WAS GOOD AND IT FIT PERFECTLY, AND SHE HAD FULL CONFIDENCE WHEN DOING THE SURGERY. THE SURGERY STARTED AROUND 3:30PM ON (B)(6) 2016. THE DENTIST REPORTS, SHE DID CHECK THE GUIDE ON THE MODEL WHEN IT ARRIVED AT HER OFFICE, AND BEFORE STARTING THE SURGERY. THE FIT WAS AGAIN EVALUATED IN THE MOUTH AND ALL WAS GOOD TO GO. THE ONLY CHANGE SHE MADE EVEN BEFORE THE SURGERY WAS THAT SHE DECIDED THAT A 3.5MMX10MM IMPLANT WAS BETTER AS SHE NORMALLY USES THE ADJACENT TEETH AS A GUIDE TO SELECT THE IMPLANT LENGTH- OF COURSE, KEEPING IN MIND THE BIOMECHANICS OF IMPLANTS AND ANY PARAFUNCTIONAL HABITS ONE MAY HAVE, ETC.. SHE HAD CHOSEN A SMALL DIAMETER IMPLANT AS THE B-L BONE WIDTH WAS NOT GREAT. SO SHE HAD INITIALLY CHOSEN THE LONGER IMPLANT, 11.5MM, BUT UNDERSTANDING THAT A 10MM IMPLANT WOULD STILL GIVE A NICE STABILITY, SHE DECIDED ON THE 3.5MMX10MM. THAT WAS THE ONLY CHANGE MADE COMPARED TO HER INITIAL PLANNING, EVEN BEFORE SHE GOT THE SICAT OPTIGUIDE FROM SICAT. SO THE SURGERY WAS UNREMARKABLE - SHE STARTED WITH A TISSUE PUNCH USING THE GUIDE, THEN THE INITIAL DRILL WITH THE GUIDE, THEN THE REST OF THE OSTEOTOMY ALSO WITH THE GUIDE, AND THE IMPLANT WAS ALSO PLACED WITH THE GUIDE, AND THE LAST TURN, SHE HAND-TORQUED SINCE THE MOTOR WASN'T LETTING HER GO TO DEPTH. THE ONLY THING SHE NOTICED WHEN SHE WAS DOING THE OSTEOTOMY, SHE DID FEEL SOME RESISTANCE, BUT EVEN THEN, SHE DID NOT DOUBT AS THE FIT OF THE OPTIGUIDE WAS THE BEST SHE HAD SEEN SO FAR ("HAD MY DRILLS BEEN DULL, I WOULD HAVE FELT MORE RESISTANCE AND STOPPED. THESE WERE BRAND NEW DRILLS I USED FOR THIS SURGERY"). AFTER THE HEALING ABUTMENT WAS PLACED AND SHE DISCUSSED POST-OPERATIVE INSTRUCTIONS AND ALL, SHE TOOK THE 3D XRAY TO CONFIRM THE PLACEMENT. SHE NOTICED ALMOST THE ENTIRE LINGUAL WALL ALONG THE LENGTH OF THE IMPLANT HAD BEEN PERFORATED. SHE IMMEDIATELY REMOVED THE IMPLANT AND SUTURED THE SITE. NO BONE GRAFT WAS PLACED AT THAT TIME. THE DENTIST HAS BEEN FOLLOWING UP ON THE PATIENT. THE PATIENT HAS BEEN SCHEDULED TO HAVE GBR AND WILL HAVE AN IMPLANT PLACED ONCE THE SITE HEALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264978 SICAT OPTIGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention HIOSSEN ET III SA IMPLANT SYSTEM (ET3M3510S)