BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP

    MDR report key: 7546863 · Received May 25, 2018

    Report

    Report Number
    3011649314-2018-00157
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    April 10, 2018
    Report Date
    August 22, 2018
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS WERE MADE FOR SECTIONS BELOW AS PRODUCT INFORMATION WAS CORRECTED BY DISTRIBUTOR: BRAND NAME: CHANGED FROM INCLUSIVE TAPERED IMPLANT 3.7 MMD X 11.5 MML X 3.5 MMP TO INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP. COMMON DEVICE NAME: CHANGED FROM INCLUSIVE TAPERED IMPLANT 3.7 MMD X 11.5 MML X 3.5 MMP TO INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP. MODEL#: AND CATALOG#: CHANGED FROM 70-1070-IMP0007 TO 70-1070-IMP0012. LOT#: CHANGED FROM 6032587 TO 6024271. EXPIRATION DATE: CHANGED FROM 05-JAN-2022 TO 22-FEB-2021. UDI#: CHANGED FROM (B)(4) TO (B)(4) DEVICE MANUFACTURE DATE: CHANGED FROM 05-JAN-2017 TO 22-FEB-2016. 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 LACK OF 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 COULD ALSO BE A FACTOR CAUSING THE IMPLANT TO LOSE OSSEOINTEGRATION. 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 WITH 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).THE REPORTED DEVICE IS BEING RETURNED BY THE DISTRIBUTOR. ONCE THE DEVICE'S 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 FAILED ABOUT A MONTH AFTER IT WAS PLACED INTO THE TOOTH # 19 (UNIVERSAL). THE IMPLANT SITE WAS NOT INFECTED. THE IMPLANT SITE HAS TYPE II BONE QUALITY. THE PATIENT HAS NO RELEVANT PRE-EXISTING CONDITION. THE PATIENT WAS REPORTED TO BE DOING FINE. THERE WAS NO ABNORMALITY WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386792 INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP INCLUSIVE TAPERED IMPLANT 4.7 MMD X 11.5 MML X 4.5 MMP DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0012 6024271

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR