BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE TAPERED IMPLANT 5.2MMD X 8MML X 4.5 MMP

    MDR report key: 23535179 · Received November 12, 2025

    Report

    Report Number
    3011649314-2025-01365
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    July 12, 2025
    Report Date
    December 18, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H8. THE DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION HAS BEEN COMPLETED. THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR INCLUSIVE TAPERED IMPLANT LOT# 6040487 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# 6040487 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN THE ORIGINAL PACKAGE. AN ABUTMENT WAS ATTACHED TO THE IMPLANT. THE IMPLANT WAS VERIFIED TO BE AN INCLUSIVE TAPERED IMPLANT 5.2MMD X 8MML X 4.5 MMP (70-1070-IMP0015) USING THE RADIOGRAPHIC TEMPLATE (GD-437-091015). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. MATTER 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 DESCRIPTION: "FAILURE TO OSSEOINTEGRATE" IS A COMMON COMPLAINT IN REGARD 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 FAILURE TO OSSEOINTEGRATE IS INCONCLUSIVE AND SPECIFIC TO EACH CASE, PROBABLE CAUSES 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, PATIENT'S HEALTH, PERI-IMPLANTITIS, SMOKING, AND LACK OF ORAL HYGIENE MAY ALSO BE CONTRIBUTING FACTORS. IFU-4989 REV 2 (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 2 (INCLUSIVE TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE SURGICAL PROCEDURES UNDER THE PRECAUTION SECTION: "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." IFU-4989 REV 2 (INCLUSIVE TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE 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 2 (INCLUSIVE TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE 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." PER THE REPORTED INFORMATION, THE EXPIRATION DATE OF THE IMPLANT WAS PRIOR TO THE IMPLANT PLACEMENT DATE. IFU-4989 REV 2 (INCLUSIVE TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE STERILITY SECTION: "THEY ARE FOR SINGLE USE ONLY, PRIOR TO THE EXPIRATION DATE." MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE EVALUATION OF THE DEVICE IS PENDING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, A3, B3, B5, D1, D2A, D4, D6A, D6B, D9, H4, H6 (HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE) CORRECTED INFORMATION: G4, H6 (MEDICAL DEVICE PROBLEM CODE) PATIENT RACE/ETHNICITY AND WEIGHT WERE REPORTED AS NA MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE IMPLANT FAILED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT REPORTED DEVICE WAS IMPLANTED ON (B)(6) 2025 ON TOOTH POSITION #19. THE PATIENT WAS DOING FINE DURING INITIAL POST-OP VISIT ON (B)(6) 2025. THE PATIENT RETURNED ON (B)(6) 2025 AND COMPLAINED OF PAIN. DURING THE EXAMINATION, THE DOCTOR NOTED INFECTION AND DETERMINED THAT THE IMPLANT FAILED TO OSSEOINTEGRATE. THE REPORTED DEVICE WAS EXPLANTED ON (B)(6) 2025 AND THE SITE WAS GRAFTED AND ALLOWED TO HEAL. A REPLACEMENT DEVICE WAS IMPLANTED ON (B)(6) 2025 AND THE PATIENT IS NOW DOING FINE. THERE WAS NO PERMANENT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544965 INCLUSIVE TAPERED IMPLANT 5.2MMD X 8MML X 4.5 MMP INCLUSIVE TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0015 6040487

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention