BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

    MDR report key: 22650758 · Received July 29, 2025

    Report

    Report Number
    3011649314-2025-00851
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    May 5, 2025
    Report Date
    October 13, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT'S ETHNICITY/RACE WAS REPORTED AS WHITE BY THE HEALTHCARE PROFESSIONAL. DEVICE EVALUATION HAS BEEN COMPLETED; FOLLOWING IS THE DEVICE ANALYSIS CONCLUSION: DHR RESULTS. THE DHR WAS REVIEWED FOR GLIDEWELL HT IMPLANT LOT# 6242925 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# 6242925 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 A GLIDEWELL HT IMPLANT Ø4.3 X 10 MM (70-1189-IMP0010) 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 WHERE THE ABUTMENT WOULD NOT SEPARATE FROM THE IMPLANT. THE PROBABLE CAUSE FOR THIS FAILURE MAY BE DUE TO OVER TORQUING OF THE ABUTMENT WHICH MAY HAVE CAUSE THE ABUTMENT TO HAVE A TIGHT FIT TO THE IMPLANT, MAKING IT DIFFICULT TO SEPARATE THE ABUTMENT AND IMPLANT. THE OVERTORQUING COULD BE DUE TO NOT FOLLOWING THE INSTRUCTIONS. CORRECTIVE ACTION. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME SINCE THE ROOT CAUSE WAS INCONCLUSIVE. BASED ON THE DHR REVIEW, THERE IS NO PRODUCT DEFORMITY OR NON-CONFORMITY. THERE WAS NO EVIDENCE FOUND TO INDICATE THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE EVALUATION IS PENDING. AT THE COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE ANALYSIS CONCLUSION. THE PROBABLE ROOT CAUSE OF THE EVENT HAS NOT YET BEEN IDENTIFIED. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER THE ABUTMENT ATTACHMENT A GLIDEWELL HT TAPERED IMPLANT WAS REMOVED DUE TO THE HEALING ABUTMENT WELDING TO THE IMPLANT, ON TOOTH NUMBER 22. PER THE REPORT THEY TRIED TO REMOVE THE HEALING ABUTMENT WITH A TORQUE WRENCH, BUT THE PATIENT EXPERIENCED SEVERE PAIN. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER OBSERVED THE FOLLOWING PATIENT SYMPTOM: PAIN. PER THE REPORT THE DEVICE WAS REMOVED, AND NO ADDITIONAL PROCEDURES WERE PERFORMED, AND THE DEVICE WAS REPLACED. IT WAS REPORTED THAT AT THE TIME OF THE SURGICAL PROCEDURE THE PATIENT'S BONE QUALITY WAS TYPE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1411435 GLIDEWELL HT IMPLANT Ø4.3 X 10 MM GLIDEWELL HT TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1189-IMP0010 6242925

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention