BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.7MMD X 11.5MML X 3.5MMP

    MDR report key: 8933190 · Received August 26, 2019

    Report

    Report Number
    3011649314-2019-00408
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    July 10, 2019
    Report Date
    November 15, 2019
    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

    CORRECTION: DEVICE BRAND NAME CORRECTED TO INCLUSIVE TAPERED IMPLANT 3.7MMD X 11.5MML X 3.5MMP. THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DEVICE HISTORY RECORD 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. RETURNED SAMPLE: CUSTOMER DID NOT RETURN THE COMPLAINT PART FOR INVESTIGATION. ROOT CAUSE: 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." 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." 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 IN THE FAILED OSSEOINTEGRATION OF THE IMPLANT. SMOKING IS KNOWN TO INHIBIT LOCAL WOUND HEALING AND MAY AFFECT SURVIVAL OF IMPLANTS. SMOKING HAS A STRONG INFLUENCE ON THE COMPLICATION RATES OF IMPLANTS. IT CAUSES SIGNIFICANTLY MORE MARGINAL BONE LOSS AFTER IMPLANT PLACEMENT, INCREASED THE INCIDENCE OF PERI-IMPLANTITIS (DEEP MUCOSAL POCKETS AROUND DENTAL IMPLANTS, INFLAMMATION OF THE PERI-IMPLANT MUCOSA, AND INCREASED RESORPTION OF PERI-IMPLANT BONE, AND AFFECTS THE SUCCESS RATES OF BONE GRAFTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE PATIENT'S RACE AND ETHNICITY WERE NOT PROVIDED; HOWEVER, THE PATIENT'S NATIONALITY IS LISTED AS TURKISH. THIS IS THE FIRST OF TWO IMPLANT COMPLAINTS, SEE MANUFACTURER REPORT FOR THE SECOND COMPLAINT : 3011649314-2019-00407 ((B)(6)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT FAILED. THE PATIENT HAS A HISTORY OF EDENTULOUS DENTATION AND A BONE GRADE TYPE III. THE PATIENT ALSO A HISTORY OF SMOKING. THE PATIENT PRESENTED ON (B)(6) 2019 FOR PRIMARY PROCEDURE ON TOOTH #21 (UNIVERSAL). ON (B)(6) 2019 THE PATIENT PRESENTED WITH MOBILITY. UPON EXAMINATION, THE PROVIDER NOTES A LACK OF STABILITY. IT WAS AT THAT TIME THE DEVICE WAS REMOVED. THE PATIENT CURRENT STATUS IS "FINE NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723238 INCLUSIVE TAPERED IMPLANT 3.7MMD X 11.5MML X 3.5MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0007 6049751

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR