BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

    MDR report key: 23723335 · Received December 4, 2025

    Report

    Report Number
    3011649314-2025-01518
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    July 14, 2025
    Report Date
    March 2, 2026
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. THE EVALUATION OF THE DEVICE IS PENDING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER'S INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: D9. THE DEVICE WAS RETURNED. THE INVESTIGATION HAS BEEN UPDATED, AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS THE DHR WAS REVIEWED FOR LOT#6232218 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 THE STOCK PRODUCT FOR LOT#6232218 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. INVESTIGATION METHODS/RESULTS THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A GLIDEWELL HT IMPLANT Ø4.3 X 8 MM (70-1189-IMP0009) 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 PER THE REPORTED INFORMATION, THERE WAS A FIT ISSUE. THE PROBABLE CAUSE FOR THIS ISSUE MAY BE DUE TO AN OVER PREPARED OSTEOTOMY. 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 THE GLIDEWELL HT IMPLANT FAILED. THE PATIENT PRESENTED ON (B)(6) 2025 FOR A PRIMARY PROCEDURE ON TOOTH #19. THE PATIENT RETURNED ON (B)(6) 2025 WITHIN 3 WEEKS OF IMPLANT PLACEMENT. UPON EXAMINATION, THE PROVIDER NOTED THE IMPLANT WAS LOOSE AND WAS REMOVED. NO PERMANENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2867641 GLIDEWELL HT IMPLANT Ø4.3 X 8 MM GLIDEWELL HT IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1189-IMP0009 6232218

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male