BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TAPERED IMPLANT 4.2 MMD X 11.5 MML X 3.5 MMP

    MDR report key: 7636351 · Received June 25, 2018

    Report

    Report Number
    3011649314-2018-00201
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    February 25, 2018
    Report Date
    September 24, 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

    PRODUCT'S INFORMATION WAS CORRECTED BY DISTRIBUTOR. CHANGES WERE MADE FOR SECTIONS BELOW: BRAND NAME - CHANGED FROM INCLUSIVE TAPERED IMPLANT 3.7 MMD X 11.5 MML X 3.5 MMP TO INCLUSIVE TAPERED IMPLANT 4.2 MMD X 11.5 MML X 3.5 MMP. MODEL # AND CATALOG # - CHANGED FROM 70-1070-IMP0007 TO 70-1070-IMP0028. LOT # - CHANGED FROM 6049751 TO 6040353. EXPIRATION DATE - CHANGED FROM 18-DEC-2022 TO 23-MAR-2022. UDI # - CHANGED FROM (B)(4) TO (B)(4). DEVICE MANUFACTURE DATE - CHANGED FROM 18-DEC-2017 TO 23-MAR-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 FAILED 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 COULD ALSO BE A FACTOR CAUSING THE IMPLANT TO LOSE OSSEOINTEGRATION. 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 IS POSSIBLE THAT THE PATIENT'S BONE QUALITY MAY HAVE BEEN A FACTOR IN THE FAILED TO ACHIEVE PRIMARY STABILITY OF THE IMPLANT. PER PROVIDED INFORMATION, THE PATIENT HAS A HISTORY OF SMOKING. SMOKING IS A KNOWN TO INHIBIT LOCAL WOUND HEALING AND MAY AFFECT SURVIVAL RATE OF IMPLANTS. SMOKING IS KNOWN TO HAVE A STRONG INFLUENCE ON THE COMPLICATION RATE OF IMPLANTS. IT CAUSES SIGNIFICANTLY MORE MARGINAL BONE LOSS AFTER IMPLANT PLACEMENT, INCREASES THE INCIDENCE OF INFECTION, 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. 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." THERE WAS NO NON-CONFORMITY FOUND WITH THE REPORTED IMPLANT. 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 IMPLANT IS BEING RETURNED BY THE DISTRIBUTOR. ONCE 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 DISCOVERED TO BE FAILING DURING THE REMOVAL OF HEALING CAP. THE IMPLANT SITE WAS NOT INFECTED. THE IMPLANT WAS EXTRACTED ABOUT 3.5 MONTHS AFTER IT WAS PLACED INTO THE TOOTH # 12 (UNIVERSAL). THE IMPLANT SITE HAS TYPE III BONE QUALITY. THE PATIENT HAS HISTORY OF SMOKING. THE PATIENT IS HEALING. THERE WAS NO ABNORMALITY NOTED FOR THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477035 INCLUSIVE TAPERED IMPLANT 4.2 MMD X 11.5 MML X 3.5 MMP DENTAL IMPLANT, INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0028 6040353

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR