BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE TAPERED IMPLANT 4.2 MMD X 10 MML X 3.5 MMP

    MDR report key: 9719798 · Received February 18, 2020

    Report

    Report Number
    3011649314-2020-00205
    Event Type
    Injury
    Date Received
    February 18, 2020
    Date of Event
    October 7, 2019
    Report Date
    February 11, 2021
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Adverse Event
    Yes
    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. 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# 6061107 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS 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: 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. IN ADDITION, IFU 3023579 REV 3.0 (INCLUSIVE DENTAL IMPLANT SYSTEM) 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. 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. AVAILABLE FOR REVIEW.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENT REPORT WILL BE SUBMITTED. THIS MW 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 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 REMAINING COMPLAINT. 3011649314-2020-00206 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT FAILED. THE PATIENT HAS BONE GRADE TYPE III. THE PATIENT HAS A HISTORY OF SMOKING. HOWEVER, THERE IS NO OTHER MEDICAL OR DENTAL HISTORY PRIOR TO IMPLANT. THE PATIENT PRESENTED ON (B)(6) 2019 FOR PRIMARY PROCEDURE ON TOOTH #20(UNIVERSAL). ON (B)(6) 2019 THE PATIENT PRESENTED FOR SECOND STAGE OF THE PROCEDURE WITH COMPLAINTS OF PAIN AND INFECTION. UPON EXAMINATION, THE PROVIDER NOTES A LACK OF PRIMARY STABILITY AND INFECTION. IT WAS AT THAT TIME THE DEVICE WAS REMOVED. THE PROVIDER STATES THE PATIENT CURRENT STATUS AS "WE CLEARED INFECTION AROUND OF IMPLANT AND PATIENT IS FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185627 INCLUSIVE TAPERED IMPLANT 4.2 MMD X 10 MML X 3.5 MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0027 6061107

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention