BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.7 MMD X 8 MML X 3.5 MMP

    MDR report key: 17244199 · Received July 1, 2023

    Report

    Report Number
    3011649314-2023-00400
    Event Type
    Injury
    Date Received
    July 1, 2023
    Date of Event
    March 29, 2023
    Report Date
    May 19, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED, THE DEVICE EVALUATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR INCLUSIVE TAPERED IMPLANT LOT# 6111904 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: A REVIEW OF STOCK PRODUCT WAS PERFORMED FOR INCLUSIVE TAPERED IMPLANT LOT# 6111904 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE AN INCLUSIVE TAPERED IMPLANT 3.7 MMD X 8 MML X 3.5 MMP (70-1070-IMP0005) USING RADIOGRAPHIC TEMPLATE (B)(4). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. BONE DEBRIS WAS OBSERVED IN THE THREADING OF THE IMPLANT. THE COMPLAINT IS VERIFIED BASED ON THE RETURNED PART BUT CANNOT CONFIRM THE FAILURE MODE. THERE WAS NO EVIDENCE FOUND THAT INDICATED THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. ROOT CAUSE: "LOSS OF OSSEOINTEGRATION" IS A COMMON COMPLAINT IN REGARDS TO IMPLANT FAILURE. THIS OCCURS WHEN THE PATIENT'S BONE DOES NOT INTEGRATE WITH THE IMPLANT SURFACE. THE POSSIBLE RESPONSES TO THIS COMPLAINT COULD BE ATTRIBUTED TO VARIOUS CAUSES. ALTHOUGH THE ROOT CAUSE FOR LOSS OF OSSEOINTEGRATION IS INCONCLUSIVE AND SPECIFIC TO EACH CASE, PROBABLE CAUSES COULD BE THE LOSS 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. PREMATURE LOADING, PATIENT'S HEALTH, PERI-IMPLANTITIS, SMOKING, AND LACK OF ORAL HYGIENE MAY ALSO BE CONTRIBUTING FACTORS. IFU-4989 REV. 5 (INCLUSIVE TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE CONTRAINDICATIONS SECTION: "INCLUSIVE TAPERED IMPLANTS SHOULD NOT BE PLACED IN PATIENTS DISCOVERED TO BE MEDICALLY UNFIT FOR THE INTENDED TREATMENT. PRIOR TO CLINICAL INTERVENTION, PROSPECTIVE PATIENTS MUST BE THOROUGHLY EVALUATED FOR ALL KNOWN RISK FACTORS AND CONDITIONS RELATED TO ORAL SURGICAL PROCEDURES AND SUBSEQUENT HEALING. CONTRAINDICATIONS INCLUDE BUT ARE NOT LIMITED TO: VASCULAR CONDITIONS, UNCONTROLLED DIABETES, CLOTTING DISORDERS, ANTICOAGULANT THERAPY, METABOLIC BONE DISEASE, CHEMOTHERAPY OR RADIATION THERAPY, CHRONIC PERIODONTAL INFLAMMATION, INSUFFICIENT SOFT TISSUE COVERAGE, METABOLIC OR SYSTEMIC DISORDERS ASSOCIATED WITH WOUND AND/OR BONE HEALING, USE OF PHARMACEUTICALS THAT INHIBIT OR ALTER NATURAL BONE REMODELING, ANY DISORDERS WHICH INHIBIT A PATIENT'S ABILITY TO MAINTAIN ADEQUATE DAILY ORAL HYGIENE, UNCONTROLLED PARAFUNCTIONAL HABITS, INSUFFICIENT HEIGHT AND/OR WIDTH OF BONE, AND INSUFFICIENT INTERARCH SPACE." IFU-4989 REV. 5 (INCLUSIVE TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN WARNING SECTION: "THE IMPLANT SITE SHOULD BE INSPECTED FOR ADEQUATE BONE BY RADIOGRAPHS, PALPATIONS AND VISUAL EXAMINATION. DETERMINE THE LOCATION OF NERVES AND OTHER VITAL STRUCTURES AND THEIR PROXIMITY TO THE IMPLANT SITE BEFORE ANY DRILLING TO AVOID POTENTIAL INJURY, SUCH AS PERMANENT NUMBNESS TO THE LOWER LIP AND CHIN." IFU-4989 REV. 5 (INCLUSIVE TAPERED 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." IFU-4989 REV. 5 (INCLUSIVE TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN PRECAUTION SECTION SURGICAL PROCEDURES: "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. FOR BEST RESULTS, PLEASE OBSERVE THE FOLLOWING PRECAUTIONS: ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL, 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. SINCE IMPLANT COMPONENTS AND THEIR INSTRUMENTS ARE VERY SMALL, PRECAUTIONS SHOULD BE TAKEN TO ENSURE THAT THEY ARE NOT SWALLOWED OR ASPIRATED BY THE PATIENT. PRIOR TO SURGERY, ENSURE THAT THE NEEDED COMPONENTS, INSTRUMENTS AND ANCILLARY MATERIALS ARE COMPLETE, FUNCTIONAL AND AVAILABLE IN THE CORRECT QUANTITIES."

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B1, B2, B5, H6. CORRECTED INFORMATION: A2, G1, G4. CAPA CA-00016. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. IF/ WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES. SECTION A A4: PATIENT'S WEIGHT WAS NOT PROVIDED. A6: PATIENT'S RACE WAS NOT PROVIDED. SECTION B B3: DATE OF EVENT WAS NOT PROVIDED. SECTION D D6A: IMPLANT DATE WAS NOT PROVIDED. D6B: EXPLANT DATE WAS NOT PROVIDED THIS IS THE 2ND OF 3 FAILED IMPLANTS REPORTED ON THE SAME PATIENT. REFERENCE THE FOLLOWING MANUFACTURER REPORTS FOR THE REMAINING IMPLANTS. 3011649314-2023-00399 3011649314-2023-00401 .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT LOST INTEGRATION. THE PATIENT'S BONE TYPE IS TYPE III. THE PATIENT HAD PAIN, BONE LOSS, AND THE IMPLANT SITE WAS INFECTED. THE PATIENT'S SYMPTOMS HAVE BEEN RELIEVED AFTER REMOVAL OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT LOST INTEGRATION. THE PATIENT'S BONE TYPE IS TYPE III. THE PATIENT PRESENTED FOR PRIMARY PROCEDURE ON TEETH NUMBERS 27, 28, AND 31 ON (B)(6) 2021. THE PATIENT RETURNED ON (B)(6) 2023 WITH THE PROVIDER REPORTED THE PATIENT HAD PAIN, BONE LOSS, AND THE IMPLANT SITE WAS INFECTED. THE PATIENT'S SYMPTOMS HAVE BEEN RELIEVED AFTER REMOVAL OF DEVICE. THERE WAS NO PATIENT INJURY AND BONE GRAFTING WAS PERFORMED. THE PATIENT STATUS WAS REPORTED AS GOOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCLUSIVE TAPERED IMPLANT LOST INTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344892 INCLUSIVE TAPERED IMPLANT 3.7 MMD X 8 MML X 3.5 MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0005 6111904

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention