BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVER SCREW

    MDR report key: 21560778 · Received March 10, 2025

    Report

    Report Number
    3011649314-2025-00200
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 11, 2025
    Report Date
    October 19, 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 DEVICE IS EXPECTED TO BE RETURNED. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H11. 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. THE STOCK PRODUCT FOR LOT#6220385 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED INVESTIGATION METHODS/RESULTS. CUSTOMER HAS NOT RETURNED THE REPORTED DEVICE FOR REVIEW TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE DESCRIPTION. A ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. IT IS UNKNOWN IF THE CUSTOMER WAS USING THE CORRECT RESPECTIVE MATING PART (STRAUMANN BONE LEVEL NC). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A COVER SCREW THAT IS INSERTED INTO THE GLIDEWELL HT IMPLANT Ø5.0 X 10 MM SEIZED THE IMPLANT AND DID NOT UNSCREW WHEN THE IMPLANT WAS READY TO BE RESORTED. THE PATIENT'S BONE QUALITY IS TYPE II AND THE PATIENT'S ORAL HYGIENE IS REPORTED AS GOOD. THE PATIENT PRESENTED ON (B)(6) 2024 FOR A PRIMARY PROCEDURE ON TOOTH #18. THE PATIENT RETURNED ON (B)(6) 2025, UPON EXAMINATION THE PROVIDER NOTICED THAT WHEN EXPOSING THE IMPLANT, THE COVER SCREW DID NOT UNSCREW AND BECAME ONE WITH IMPLANT, WHEN ATTEMPTING TO UNSCREW THE IMPLANT CAME OUT. AFTER THE IMPLANT WAS REMOVED A BONE PLUG WAS PUT IN THE SOCKET AND SUTURED, IMPLANT REPLACEMENT HAS NOT YET BEEN PERFORMED. NO REPORTS OF PATIENT HARM OR INJURY. IT IS REPORTED THAT THE PATIENT IS A HEALTHY INDIVIDUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198315 COVER SCREW GLIDEWELL HT IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention