BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE TAPERED IMPLANT 4.2 MMD X 8 MML X 3.5 MMP

    MDR report key: 7576423 · Received June 6, 2018

    Report

    Report Number
    3011649314-2018-00176
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 6, 2018
    Report Date
    September 4, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT'S LOT INFORMATION WAS CORRECTED BY DISTRIBUTOR. CORRECTIONS WERE MADE TO THESE SECTIONS BELOW: DEVICE NAME CHANGED FROM INCLUSIVE TAPERED IMPLANT 3.7 MMD X 13 MML X 3.5 MMP TO INCLUSIVE TAPERED IMPLANT 4.2 MMD X 8 MML X 3.5 MMP. COMMON NAME CHANGED FROM INCLUSIVE TAPERED IMPLANT 3.7 MMD X 13 MML X 3.5 MMP TO INCLUSIVE TAPERED IMPLANT 4.2 MMD X 8 MML X 3.5 MMP. MODEL # AND CATALOG # CHANGED FROM 70-1070-IMP0008 TO 70-1070-IMP0026. LOT # CHANGED FROM 6033005 TO 6040297. EXPIRATION DATE CHANGED FROM 27-JAN-2022 TO 22-FEB-2022. UDI CHANGED FROM (B)(4). DEVICE REC'D BY MFR CHANGED FROM 27-JAN-2017 TO 22-FEB-2017. THE DEVICE WAS RETURNED AND EVALUATED. A VISUAL AND MICROSCOPIC INSPECTION WAS 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 LOSS OF OSSEOINTEGRATION IS INCONCLUSIVE AND SPECIFIC TO EACH CASE, PROBABLE COULD BE 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. PREMATURE LOADING CAN ALSO BE A FACTOR. PER PROVIDED INFORMATION, THE PATIENT HAS TYPE III BONE QUALITY. TYPE III BONE QUALITY IS A THIN CORTICAL BONE WITH DENSE TRABECULAR BONE OF GOOD STRENGTH. IT IS POSSIBLE THAT THE PATIENT'S BONE QUALITY MAY HAVE BEEN A FACTOR IN THE FAILED OSSEOINTEGRATION OF THE IMPLANT. ADDITIONALLY, 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. THE PATIENT ALSO HAS BAD ORAL HYGIENE. PATIENTS WITH BAD ORAL HYGIENE MAY NOT BE ABLE TO MAINTAIN CLEANLINESS AND ADEQUATE PLAQUE REMOVAL AROUND IMPLANTS. THIS MAY ENCOURAGE PERIMUCOSITIS AND PERI-IMPLANTITIS LEADING TO IMPAIRED HEALING. 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 ARE PROVIDED IN THE IFU THAT STATE, "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." NO ABNORMALITY WITH THE IMPLANT WAS CONFIRMED, 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 LOST OSSEOINTEGRATION AND LACKED OF PRIMARY STABILITY. THERE WERE LESIONS AROUND THE IMPLANT. THE IMPLANT SITE WAS NOT INFECTED. THE IMPLANT WAS EXTRACTED 3 MONTHS AFTER IT WAS PLACED INTO THE TOOTH # 23 (UNIVERSAL). THE IMPLANT SITE HAS TYPE III BONE QUALITY. THE PATIENT HAS BAD ORAL HYGIENE. THE PATIENT HAS HISTORY OF SMOKING. THE LESIONS AROUND IMPLANT WERE CLEARED AND NEW IMPLANT WILL BE PLACED. THERE WAS NO ABNORMALITY WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417161 INCLUSIVE TAPERED IMPLANT 4.2 MMD X 8 MML X 3.5 MMP INCLUSIVE TAPERED IMPLANT 4.2 MMD X 8 MML X 3.5 MMP DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0026 6040297

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R