BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 11.5 MML X 3.5 MMP

    MDR report key: 8283644 · Received January 28, 2019

    Report

    Report Number
    3011649314-2018-00547
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    August 26, 2018
    Report Date
    April 28, 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

    ADDITIONAL INFORMATION WAS UPDATED TO CONCOMITANT MEDICAL PRODUCTS - PRODUCT WAS RETURNED TO MANUFACTURER ON (B)(6)2019. ADDITIONAL INFORMATION WAS UPDATED TO - LOT # - 6032587 ADDITIONAL INFORMATION WAS UPDATED TO - UDI # - (B)(4) /(B)(4). ADDITIONAL INFORMATION WAS UPDATED TO - EXPIRATION DATE - 05-JAN-2022 ADDITIONAL INFORMATION WAS UPDATED TO - DEVICE MANUFACTURE DATE - 05-JAN-2017 THE DEVICE WAS RETURNED AND EVALUATED. A VISUAL AND MICROSCOPIC INSPECTION WERE PERFORMED ON THE RETURNED DEVICE AND NO DEVIATIONS WERE FOUND. THE CRITICAL PARAMETERS OF THE IMPLANT WERE MEASURED AND NO DEFECTS, NOR NON-CONFORMITIES WERE FOUND. A LOT NUMBER WAS RECEIVED AND A DEVICE HISTORY RECORD REVIEW (DHR) WAS CONDUCTED. THERE WAS NO EVIDENCE DISCOVERED, TO INDICATE THAT A PRODUCT DEFECT OR NONCONFORMITY CONTRIBUTED TO THE ISSUE. THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. ALTHOUGH THE ROOT CAUSE FOR FAILURE TO ACHIEVE PRIMARY STABILITY IS INCONCLUSIVE AND SPECIFIC TO EACH CASE, PROBABLE CAUSES COULD BE DUE TO INSUFFICIENT BONE OR POOR BONE QUALITY. THE BONE COULD BE TOO SOFT OR THE OPERATOR ERRED IN CREATING AN OSTEOTOMY BIGGER THAN THE SIZE OF THE IMPLANT DIAMETER. PREMATURE LOADING, PATIENT'S HEALTH, PERI-IMPLANTITIS, TOBACCO USE AND POOR ORAL HYGIENE COULD ALSO BE THE FACTORS CAUSING THE IMPLANT TO FAIL TO ACHIEVE PRIMARY STABILITY. IT WAS REPORTED THAT THE PATIENT HAS TYPE III BONE QUALITY. TYPE III BONE HAS A THIN LAYER OF CORTICAL BONE SURROUNDING MEDIUM-DENSITY SPONGY BONE. IT HAS BEEN SHOWN THAT THE QUALITY AND QUANTITY OF BONE AVAILABLE AT THE IMPLANT SITE ARE VERY IMPORTANT PATIENT FACTOR IN DETERMINING THE SUCCESS OF DENTAL IMPLANTS. IT IS DIFFICULT TO OBTAIN IMPLANT ANCHORAGE IN BONE THAT IS NOT VERY DENSE. IT IS POSSIBLE THAT THE PATIENT'S BONE QUALITY MIGHT HAVE CONTRIBUTED TO THE IMPLANT'S FAILURE TO ACHIEVE PRIMARY STABILITY. A WARNING PROVIDED IN THE IFU STATES "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." PRECAUTIONS IN THE IFU ALSO STATE THAT "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, COPIOUS IRRIGATION. ALL SURGICAL INSTRUMENTS 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 OF THE IMPLANT SITE. THE PROPER SURGICAL PROTOCOL SHOULD BE STRICTLY ADHERED TO." THIS EVENT WILL BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    PATIENT'S RACE AND ETHNICITY WERE NOT PROVIDED; HOWEVER, THE PATIENT'S NATIONALITY IS (B)(6). PRODUCT'S LOT INFORMATION WAS INCORRECT. FOLLOW-UP ATTEMPTS WERE MADE TO ASK FOR THE CORRECT LOT INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN PROVIDED YET. DEVICE IS GOING TO BE RETURNED FOR EVALUATION BY THE DISTRIBUTOR. ONCE NEW INFORMATION IS OBTAINED AND THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCLUSIVE TAPERED IMPLANT FAILED TO ACHIEVE PRIMARY STABILITY. THE IMPLANT WAS FOUND TO HAVE MOBILITY WHEN THE PATIENT VISITED THE CLINIC. THE IMPLANT SITE WAS NOT INFECTED. THE IMPLANT WAS PLACED INTO THE TOOTH # 21 ON (B)(6) 2018 AND WAS EXTRACTED ON (B)(6) 2018. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT WAS REPORTED TO BE FINE. THE PATIENT HAS TYPE III BONE QUALITY. THE PATIENT HAS NO RELEVANT MEDICAL OR DENTAL PRE-EXISTING CONDITION. THERE WAS NO ABNORMALITY NOTED WITH THE IMPLANT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74390 INCLUSIVE TAPERED IMPLANT 3.7 MMD X 11.5 MML X 3.5 MMP INCLUSIVE TAPERED IMPLANT 3.7 MMD X 11.5 MML X 3.5 MMP DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0007 6032587

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR