BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.2MMD X 11.5MML X 3.0MMP

    MDR report key: 21877494 · Received April 21, 2025

    Report

    Report Number
    3011649314-2025-00351
    Event Type
    Injury
    Date Received
    April 21, 2025
    Date of Event
    March 29, 2018
    Report Date
    October 18, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K153099
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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 INCLUSIVE TAPERED IMPLANT LOT#6040347 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 INCLUSIVE TAPERED IMPLANT LOT#6040347 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE REPORTED PRODUCT HAS NOT BEEN RETURNED TO THE COMPLAINT HANDLING TEAM TO DATE THEREFORE AN ANALYSIS OF THE PHYSICAL PRODUCT COULD NOT BE PERFORMED. THE ROOT CAUSE COULD NOT BE DETERMINED AS ADDITIONAL INFORMATION WAS NOT PROVIDED. THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE PRODUCT WAS MANUFACTURED TO BE WITHIN SPECIFICATION AT THE TIME OF RELEASE. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER VIA EMAIL AND PHONE CALL. SHOULD ADDITIONAL INFORMATION BE PROVIDED BY THE CUSTOMER A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE ADDITIONAL INFORMATION RECEIVED. 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. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INCLUSIVE TAPERED IMPLANT WAS DEFECTIVE. IT WAS REPORTED THAT THE IMPLANT WAS PLACED ON (B)(6) 2017 AT TOOTH SITE # 28 AND EXPLANTED ON (B)(6) 2018. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339099 INCLUSIVE TAPERED IMPLANT 3.2MMD X 11.5MML X 3.0MMP INCLUSIVE TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0032

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention