BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.2 MMD X 11.5 MML X 3.0 MMP

    MDR report key: 9789714 · Received March 4, 2020

    Report

    Report Number
    3011649314-2020-00291
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    November 28, 2019
    Report Date
    December 24, 2020
    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 DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR 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#: 6040347 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 01/13/2020. THE FDA WAS MADE AWARE OF THE HIGH VOLUME OF COMPLAINTS BY GLIDEWELL. AN EMAIL RESPONSE WAS RECEIVED FROM THE FDA ON 02/05/2020. 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. WHEN/IF THE DEVICE IS RETURNED FOR EVALUATION, THE NEW INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE 2ND OF 3 FAILED IMPLANTS REPORTED ON THE SAME PATIENT. REFERENCE THE FOLLOWING MANUFACTURER REPORTS FOR THE REMAINING IMPLANTS: 3011649314-2020-00290 3011649314-2020-00292

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCLUSIVE IMPLANT FAILED. THE DOCTOR REPORTED THAT THE IMPLANT WAS PLACED ON (B)(6) 2019 AT TOOTH LOCATION #19 (UNIVERSAL). THE PATIENT RETURNED ON (B)(6)2019 FOR SECOND STAGE SURGERY. AFTER EXAMINATION, THE DOCTOR NOTED THAT THE IMPLANT LACKED PRIMARY STABILITY. THE IMPLANT WAS THEN REMOVED. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "FINE". THE PATIENT HAS TYPE III BONE QUALITY, AND HAS NO RELEVANT MEDICAL OR DENTAL HISTORY. THERE WAS NO ABNORMALITY NOTED WITH THE IMPLANT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252966 INCLUSIVE TAPERED IMPLANT 3.2 MMD X 11.5 MML X 3.0 MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0032 6040347

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR