BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.2MMD X 10MML X 3.0MMP

    MDR report key: 9732247 · Received February 20, 2020

    Report

    Report Number
    3011649314-2020-00137
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    November 11, 2019
    Report Date
    March 4, 2021
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, BUT DID NOT TRANSFER TO THE INVESTIGATOR. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR REVIEW RESULTS: THE DHR WAS REVIEWED AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. STOCK PRODUCT REVIEWED RESULTS: THERE WAS NO STOCK PRODUCT FROM LOT# 6050698 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED, BUT DID NOT TRANSFER TO THE INVESTIGATOR. ROOT CAUSE: PER THE REPORTED INFORMATION, THE PATIENT HAD TYPE III BONE QUALITY. IT HAS BEEN SHOWN THAT THE QUALITY AND QUANTITY OF BONE AVAILABLE AT THE IMPLANT SITE ARE VERY IMPORTANT PATIENT FACTORS, IN DETERMINING THE SUCCESS OF DENTAL IMPLANTS. IT IS DIFFICULT TO OBTAIN IMPLANT ANCHORAGE IN BONE THAT IS NOT VERY DENSE. TYPE III: THIN LAYER OF CORTICAL BONE SURROUNDING A CORE OF DENSE TRABECULAR BONE. THEREFORE, THE PATIENT'S BONE QUALITY MAY HAVE BEEN A FACTOR. PROBABLE CAUSES COULD BE THE LACK OF PRIMARY STABILITY AT THE OSTEOTOMY SITE DUE TO INSUFFICIENT BONE OR POOR BONE QUALITY; EITHER THE BONE WAS TOO SOFT OR THE OPERATOR ERRED IN CREATING AN OSTEOTOMY BIGGER THAN THE SIZE OF THE IMPLANT DIAMETER. IFU 3023579 REV 3.0 (INCLUSIVE DENTAL IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN WARNING SECTION: "ABSOLUTE SUCCESS CANNOT BE GUARANTEED. FACTORS SUCH AS INFECTION, DISEASE AND INADEQUATE BONE QUALITY AND/OR QUANTITY CAN RESULT IN OSSEOINTEGRATION FAILURES FOLLOWING SURGERY OR INITIAL OSSEOINTEGRATION." IN ADDITION, THE IFU ALSO CONTAINS THE FOLLOWING STATEMENT IN PRECAUTION SECTION: "MINIMIZING TISSUE DAMAGE IS CRUCIAL TO SUCCESSFUL IMPLANT OSSEOINTEGRATION. IN PARTICULAR, CARE SHOULD BE TAKEN TO ELIMINATE SOURCES OF INFECTION, CONTAMINANTS, SURGICAL AND THERMAL TRAUMA. RISK OF OSSEOINTEGRATION FAILURE INCREASES AS TISSUE TRAUMA INCREASES. ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL AND COPIOUS IRRIGATION. ALL SURGICAL INSTRUMENTS USED MUST BE IN GOOD CONDITION AND SHOULD BE USED CAREFULLY TO AVOID DAMAGE TO IMPLANTS OR OTHER COMPONENTS. IMPLANTS SHOULD BE PLACED WITH SUFFICIENT STABILITY; HOWEVER, EXCESSIVE INSERTION TORQUE MAY RESULT IN IMPLANT FRACTURE, OR FRACTURE OR NECROSIS OF THE IMPLANT SITE. THE PROPER SURGICAL PROTOCOL SHOULD BE STRICTLY ADHERED TO."

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS SUBMITTED LATE DUE TO AN UNEXPECTEDLY HIGH VOLUME OF COMPLAINTS FROM AN INTERNATIONAL DISTRIBUTOR ON 1-13-20. THE FDA WAS MADE AWARE OF THE HIGH VOLUME OF COMPLAINTS BY GLIDEWELL. EMAIL RESPONSE RECEIVED FROM THE FDA ON 2-5-20. THE PATIENT'S RACE AND ETHNICITY WERE NOT PROVIDED; HOWEVER, THE PATIENT'S NATIONALITY IS LISTED AS (B)(6). THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS THE FIRST OF TWO IMPLANT COMPLAINTS, SEE MANUFACTURER REPORT FOR THE REMAINING COMPLAINT : 3011649314-2020-00138 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT FAILED. THE BONE GRADE IS NOTED AS GRADE III. THE PATIENT HAS NO MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT. THE PATIENT PRESENTED ON (B)(6) 2019 FOR IMPLANT PLACEMENT ON TOOTH #22 (UNIVERSAL). ON (B)(6) 2019, THE PATIENT CAME FOR SECOND STAGE SURGERY UPON EXAM, THE PROVIDER NOTES A LACK OF STABILITY. IT WAS AT THAT TIME THE DEVICE WAS REMOVED. THE PATIENT CURRENT STATUS IS LISTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195303 INCLUSIVE TAPERED IMPLANT 3.2MMD X 10MML X 3.0MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0036 6060237

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR