BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWELL HT IMPLANT

    MDR report key: 21647442 · Received March 19, 2025

    Report

    Report Number
    3011649314-2025-00228
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 11, 2025
    Report Date
    October 8, 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS. THE DHR WAS REVIEWED FOR LOT#6220385 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. THERE IS STOCK PRODUCT FROM LOT# 6220385 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS. THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT HOLDER WAS ALSO RETURNED. THE IMPLANT WAS 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 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. A ROOT CAUSE FOR FIT ISSUES CANNOT BE EXPLICITLY DETERMINED. PROBABLE ROOT CAUSE IS IMPROPER SEATING OF THE IMPLANT DRIVER INTO THE INTERNAL HEX OF THE IMPLANT. IT IS UNCLEAR THE METHODS OF IMPLANT PLACEMENT USED DURING THE INITIAL PROCEDURE OR IF APPROPRIATE LOAD DISTRIBUTION WAS OBSERVED. IFU 012631 IF PLACING A GLIDEWELL HT IMPLANT THAT IS 3.5 MM IN DIAMETER OR GREATER, SHAPING DRILLS ARE USED SEQUENTIALLY TO WIDEN THE OSTEOTOMY TO THE MATCHING DIAMETER. TO AVOID OVER-PREPARATION, WIDENING DRILL DIAMETERS SHOULD BE USED ONLY AS NEEDED, AND IN PROPER SUCCESSION. EACH SHAPING DRILL IS LENGTH-SPECIFIC, TO MATCH THE LENGTH OF THE PRESCRIBED IMPLANT. OSTEOTOMY DEPTH MAY BE INCREASED SEQUENTIALLY, BEGINNING WITH SHORTER DRILL LENGTHS, PROVIDED SUFFICIENT DEPTH IS ACHIEVED WITH THE FINAL DRILL. SELECT THE DESIRED SHAPING DRILL, ACCOUNTING FOR BONE DENSITY AND THE SIZE OF THE IMPLANT TO BE PLACED. WITH COPIOUS IRRIGATION, DRILL TO DEPTH. THE FINAL DRILL SHOULD CORRESPOND WITH THE MATCHING IMPLANT SIZE, AS CHARTED BELOW, WITH THE GOAL OF ACHIEVING HIGH PRIMARY STABILITY UPON IMPLANT PLACEMENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A GLIDEWELL HT IMPLANT FAILED. THE PATIENT'S BONE QUALITY IS TYPE II, AND THEIR ORAL HYGIENE IS GOOD. THE PATIENT PRESENTED ON (B)(6) 2024 FOR A PRIMARY PROCEDURE ON TOOTH 18. ON (B)(6) 2025, AT THE SECOND STAGE SURGERY THE PROVIDER TRIED TO REMOVE THE COVER SCREW, AND BOTH THE SCREW AND THE IMPLANT CAME OUT STUCK TOGETHER. THE IMPLANT WAS NOT REPLACED. THE SITE WAS GRAFTED AND SUTURED, AND NO PERMANENT INJURY WAS REPORTED. PER THE REPORTED INFORMATION, THE PATIENT HAD NO PREEXISTING MEDICAL CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900967 GLIDEWELL HT IMPLANT GLIDEWELL HT IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC 70-1189-IMP0015 6220385

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention