BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWELL HT IMPLANT TITANIUM SCAN BODY - Ø3.5/4.3 IMPLANT

    MDR report key: 23101809 · Received September 19, 2025

    Report

    Report Number
    3011649314-2025-01104
    Event Type
    Injury
    Date Received
    September 19, 2025
    Report Date
    March 25, 2026
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    NHA
    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 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).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR GLIDEWELL HT IMPLANT TITANIUM SCAN BODY LOT# 6269102 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 TITANIUM SCAN BODY LOT# 6269102 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE REPORTED PRODUCT WAS RETURNED, BUT NOT IN THE ORIGINAL PACKAGING. SPECIFICATION TESTING WAS PERFORMED AND THE FINDINGS WERE THAT THE SCAN BODY AND SCREW MET SPECIFICATIONS. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE FOR THIS FAILURE CANNOT BE EXPLICITLY DETERMINED. A POTENTIAL ROOT CAUSE MAY BE DUE TO NOT FOLLOWING THE PROCEDURES PROPERLY WHICH COULD CAUSE THE COMPONENTS TO NOT FIT PROPERLY. ADDITIONALLY, IT IS UNKNOWN THE IMPLANT SYSTEM USED WITH THE SCAN BODY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). CORRECTION: H4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCAN BODY DID NOT FIT AND THAT THE SCREW DID NOT ENGAGE WITH THE IMPLANT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152768 GLIDEWELL HT IMPLANT TITANIUM SCAN BODY - Ø3.5/4.3 IMPLANT DENTAL IMPLANT ABUTMENT NHA PRISMATIK DENTALCRAFT, INC. 70-1190-PRA0055 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention