BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWELL HT IMPLANT

    MDR report key: 23184479 · Received September 30, 2025

    Report

    Report Number
    3011649314-2025-01065
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    August 19, 2025
    Report Date
    January 8, 2026
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED, AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS. NO DHR RESULTS AS NO LOT NUMBER WAS PROVIDED. STOCK PRODUCT REVIEWED RESULTS. NO STOCK PRODUCT REVIEW RESULT AS NO LOT NUMBER WAS PROVIDED. INVESTIGATION METHODS/RESULTS. CUSTOMER DID NOT RETURN THE REPORTED DEVICE FOR INVESTIGATION TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE DESCRIPTION. THE ROOT CAUSE WAS INCONCLUSIVE AND CANNOT BE EXPLICITLY DETERMINED. THE PROBABLE CAUSE FOR THE FRACTURE COULD BE CONTRIBUTED BY USER/PATIENT FACTORS. 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: "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 ADVERSE EFFECTS SECTION: "THE ABUTMENT SCREW HAS FRACTURED DUE TO APPLICATION OF EXCESSIVE TORQUE." 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).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. SHOULD THE DEVICE BE RETUNED AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FILE LINKED TO SUBMISSION NAME: 3011649314-2025-01021. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT AN IMPLANT FAILED. THE PATIENT HAS EXCELLENT ORAL HYGIENE. ON (B)(6) 2025 THE PATIENT PRESENTED FOR A PROCEDURE ON TOOTH #5. DURING IMPLANT PLACEMENT THE DRIVER HEAD BROKE OFF INSIDE THE IMPLANT AND WAS STUCK INSIDE. THE IMPLANT HAD TO BE REMOVED AND REPLACED. NO PERMANENT INJURY WAS REPORTED. PER THE REPORTED INFORMATION, THE PATIENT HAS NO PREEXISTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271984 GLIDEWELL HT IMPLANT GLIDEWELL HT IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other