BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWELL HT IMPLANT Ø5.0 X 10 MM

    MDR report key: 21344198 · Received February 10, 2025

    Report

    Report Number
    3011649314-2025-00107
    Event Type
    Injury
    Date Received
    February 10, 2025
    Date of Event
    January 7, 2025
    Report Date
    March 7, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS CURRENTLY ONGOING. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ONCE THE RETURNED DEVICE HAS BEEN EVALUATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS FILE IS LINKED TO SUBMISSION NAME: 3011649314-2025-00108. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION HAS BEEN COMPLETED; FOLLOWING IS THE DEVICE ANALYSIS CONCLUSION: DHR RESULTS: THE DHR WAS REVIEWED FOR GLIDEWELL HT IMPLANT LOT# 6240877 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 GLIDEWELL HT IMPLANT LOT# 6240877 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: 2 IMPLANTS WERE RETURNED BUT NOT IN THE ORIGINAL PACKAGING. ONE IMPLANT WAS RETURNED FOR (B)(4) AND THE OTHER IMPLANT WAS RETURNED FOR (B)(4). HOWEVER, IT COULD NOT BE DETERMINED WHICH IMPLANT WAS ASSOCIATED WITH ITS RESPECTIVE TOOTH LOCATION. THE IMPLANTS WERE VERIFIED TO BE A GLIDEWELL HT IMPLANT Ø5.0 X 10 MM (70-1189-IMP0015) USING THE RADIOGRAPHIC TEMPLATE (MKT-013579 REV 1 PK-4500230-112023). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. MATTER WAS OBSERVED IN THE TREADING OF THE IMPLANTS. 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 DEVICES. ROOT CAUSE: "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. PER THE REPORTED INFORMATION, THE PATIENT HAS A HISTORY OF THALASSEMIA. THE PATIENT ALSO HAS TYPE IV BONE QUALITY AND FAIR ORAL HYGIENE. IFU-012631 REV 1 (GLIDEWELL HT IMPLANT SYSTEM IFU) CONTAINS THE FOLLOWING STATEMENT IN THE CONTRAINDICATIONS SECTION: "GLIDEWELL HT 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-012631 REV 1 (GLIDEWELL HT IMPLANT SYSTEM IFU) 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-012631 REV 1 (GLIDEWELL HT IMPLANT SYSTEM IFU) CONTAINS THE FOLLOWING STATEMENT IN THE WARNINGS 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-012631 REV 1 (GLIDEWELL HT IMPLANT SYSTEM IFU) CONTAINS THE FOLLOWING STATEMENT IN THE WARNINGS 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." THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A GLIDEWELL HT IMPLANT WAS DEFECTIVE. THE PATIENT'S BONE QUALITY IS TYPE III AND THE PATIENT'S ORAL HYGIENE IS REPORTED AS FAIR. THE PATIENT PRESENTED ON (B)(6) 2024, FOR A PRIMARY PROCEDURE ON TEETH 14 AND 15. THE PATIENT RETURNED WITHIN THREE WEEKS OF IMPLANT PLACEMENT ON (B)(6) 2025 WITH COMPLAINT OF PAIN. UPON EXAMINATION, THE PROVIDER NOTICED INFLAMMATION, INFECTION AND GRANULATION/FIBROUS TISSUE AROUND THE IMPLANT. IT WAS DETERMINED THAT THE IMPLANT FAILED TO OSSEOINTEGRATE. THE IMPLANT WAS REMOVED ON (B)(6) 2025. AT THIS TIME, WHETHER THE IMPLANT WAS REPLACED OR NOT REMAINS INCONCLUSIVE. NO PERMANENT INJURY WAS REPORTED. PER THE REPORTED INFORMATION, THE PATIENT HAD THALASSEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754012 GLIDEWELL HT IMPLANT Ø5.0 X 10 MM GLIDEWELL HT IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1189-IMP0015 6240877

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention