BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT OPTIGUIDE

    MDR report key: 5932178 · Received September 7, 2016

    Report

    Report Number
    3006098230-2016-00002
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    August 11, 2016
    Report Date
    September 7, 2016
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DENTIST HAS NOT BEEN IN OFFICE FOR A PERIOD OF TIME. SHE IS BACK NOW AND WILL SEND DEVICE BACK TO MANUFACTURER FOR EVALUATION. EVALUATION RESULTS AND EVALUATION REPORT, AS WELL AS MISSING INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    AFTER RETURNING TO OFFICE, THE DENTIST RETURNED THE DEVICE TO THE MANUFACTURER. THE DEVICE HAS BEEN EVALUATED. THERE IS NO INDICATION THAT THE SURGICAL GUIDE MALFUNCTIONED OR WAS NOT FABRICATED ACCORDING TO THE SPECIFICATIONS. THE MOST PROBABLE SCENARIO IS THAT THE IMPLANT BED PREPARATION ALONG WITH THE HIGH BONE DENSITY PREVENTED THE IMPLANT FROM REACHING ITS FULL DEPTH. -

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT SURGICAL GUIDE (SICAT OPTIGUIDE) FOR PREPARING THE OSTEOTOMIES (DRILL HOLE FOR ACCOMMODATING A DENTAL IMPLANT) FOR TWO DENTAL IMPLANTS OF TYPE HIOSSEN ET3 SA. AFTER PREPARING THE OSTEOTOMIES THE REPORTING DENTIST DID THE IMPLANT INSERTIONS ON THE PATIENT. #20 FIXTURE WENT WELL BUT THE DENTIST REPORTS THAT #19 FIXTURE (5.0 X 10 MM) COULDN'T BE PLACED UNDER-SINK AS PLANNED. THE DENTIST THINKS THAT THE DRILLS WENT DOWN TO WHERE THEY'RE SUPPOSED TO BE. BUT THE DENTIST COULDN'T SCREW THE #19 IMPLANT DOWN MORE, AND IT STILL STICKS OUT 2MM ABOVE THE BONE SURFACE. THE DENTIST DOESN'T KNOW WHAT WENT WRONG. THE DENTIST PLANS TO REMOVE IT, PUT BONEGRAFT AND WAIT FOR HEALING, THEN WILL REPLACE THE IMPLANT.

    Description of Event or Problem · 1

    THE REPORTING DENTIST HAS USED A SICAT SURGICAL GUIDE (SICAT OPTIGUIDE) FOR PREPARING THE OSTEOTOMIES (DRILL HOLE FOR ACCOMODATING A DENTAL IMPLANT) FOR TWO DENTAL IMPLANTS OF TYPE HIOSSEN ET3 SA. AFTER PREPARING THE OSTEOTOMIES THE REPORTING DENTIST DID THE IMPLANT INSERTIONS ON THE PATIENT. #20 FIXTURE WENT WELL BUT THE DENTIST REPORTS THAT #19 FIXTURE (5.0 X 10 MM) COULDN'T BE PLACED UNDER-SINK AS PLANNED. THE DENTIST THINKS THAT THE DRILLS WENT DOWN TO WHERE THEY'RE SUPPOSED TO BE. BUT THE DENTIST COULDN'T SCREW THE #19 IMPLANT DOWN MORE, AND IT STILL STICKS OUT 2MM ABOVE THE BONE SURFACE. THE DENTIST DOESN'T KNOW WHAT WENT WRONG. ON 9/7/16 THE DENTIST INFORMED SICAT THAT SHE HAS DISCUSSED THE SITUATION WITH A COLLEAGUE AND BOTH AGREE THAT THEY WILL NOT TRY TO REMOVE IMPLANT #19 AS IT COULD CAUSE MORE HARM. THE DENTIST STATES IT IS TORQUED DOWN VERY TIGHTLY AND COULD CAUSE THE JAW TO CRACK IF THEY TRY TO RECOVER IT. SHE SAYS THERE SEEMS TO BE NO INFECTION PRESENT AND IF IT HEALS PROPERLY, THEY WILL CORRECT THE PROBLEM WITH THE ABUTMENT AND PROSTHETIC DESIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585555 SICAT OPTIGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention HIOSSEN ET III SA IMPLANT SYSTEM ((B)(4))