BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SICAT CLASSICGUIDE

    MDR report key: 7316103 · Received March 6, 2018

    Report

    Report Number
    3006098230-2018-00002
    Event Type
    Injury
    Date Received
    March 6, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 6, 2018
    Manufacturer
    SICAT GMBH & CO. KG
    Product Code
    NDP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DOES NOT GIVE ANY INDICATION FOR A SUBSTANTIAL 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. THE SLEEVE POSITION DOES NOT DEVIATE SIGNIFICANTLY FROM THE PLANNED POSITION AND CAN THEREFORE NOT BE THE REASON FOR THE PROBLEM. THE DRILLING PROTOCOL IS CORRECT AND CANNOT BE THE REASON FOR THE PROBLEM. THE ANALYSIS SUPPORTS THE FOLLOWING SCENARIO AS BEING MOST PROBABLE: THE SURGICAL GUIDE WAS NOT PUSHED DOWN COMPLETELY ON THE PATIENT'S JAW DURING SURGERY. THIS RESULTED IN A REMAINING GAP BETWEEN GUIDE AN JAW, SO THE DRILL DID NOT END UP DEEP ENOUGH. HOWEVER, AN ACRYLIC LEFTOVER ON THE GUIDE FROM PRODUCTION MIGHT HAVE ADDED TO THE MISFIT.

    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 "ASTRATECH IMPLANT SYSTEM EV". ON (B)(6) 2017, THE DENTIST PLACED THE IMPLANTS USING THE SURGICAL GUIDE AT SITES ADA #3 AND ADA #4. AT HIS FINAL OSTEOTOMY, HE NOTICED THE COLLAR OF THE IMPLANT #3 WAS AT THE LEVEL OF THE GINGIVA WHICH HE FELT WASN'T DEEP ENOUGH ACCORDING TO HIS PLANNING. HE TOOK AN X-RAY AND SAW THE APEX OF THE IMPLANT WAS STILL SEVERAL MM FROM THE SINUS. THE DENTIST CHOSE TO BACK OUT AND REMOVE THE IMPLANT. HE USED A LONGER DRILL AND PLACED THE IMPLANT AGAIN. THE DENTIST SUSPECTS, THE DRILLING PROTOCOL PROVIDED BY SICAT WITH THE GUIDE MIGHT HAVE BEEN INCORRECT. ON (B)(6) 2018 THE DENTIST INFORMED SICAT, THAT THE IMPLANT FAILED. HE REMOVED THE IMPLANT AND GRAFTED #03 SITE HEAVILY WITH BONE AND WILL ALLOW TO HEAL BEFORE ATTEMPTING ANOTHER IMPLANT IN THAT SITE. THE DENTIST THINKS THE IMPLANT FAILED BECAUSE IST WAS CONTAMINATED DURING THE PROCEDURE OF REMOVING AND REPLACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162294 SICAT CLASSICGUIDE SURGICAL GUIDE NDP SICAT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention ASTRATECH IMPLANT OS EV S, SER.# (B)(4), LENGTH 8MM