BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE TITANIUM ABUTMENT

    MDR report key: 21626385 · Received March 17, 2025

    Report

    Report Number
    3011649314-2025-00227
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Report Date
    October 19, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC
    Product Code
    NHA
    PMA / PMN Number
    K151375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. SHOULD THE DEVICE BE RETURNED AN INVESTIGATION WILL BE COMPLETED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION. 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 INCLUSIVE TITANIUM ABUTMENT BLANK LOT# 6233949 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 TITANIUM ABUTMENT BLANK LOT# 6233949 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: PER THE REPORTED INFORMATION, CUSTOMER DOES NOT HAVE THE PRODUCT TO RETURN. HOWEVER, A VIDEO WAS PROVIDED TO SHOW HOW THE ABUTMENT BLANK WAS SLIGHTLY MOVING COMPARED TO THE HIOSSEN ABUTMENT. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE COULD NOT BE EXPLICITLY DETERMINED. A POTENTIAL ROOT CAUSE IS THAT THE CONTENT OF THE WORK ORDER IS INCORRECT WHICH MAY POTENTIALLY NOT MEET THE CUSTOMER'S DESIRED SPECIFICATIONS OF THE PRODUCT. HOWEVER BASED ON THE DEVICE HISTORY RECORD, THE PRODUCT MET ALL SPECIFICATIONS PRIOR TO RELEASE. ANOTHER POTENTIAL ROOT CAUSE IS THE INCORRECT COMPONENTS WERE USED WHICH COULD CAUSE THE COMPONENTS TO NOT FIT PROPERLY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED VIA VIDEO THAT HE EXPERIENCED A FIT ISSUE WITH AN INCLUSIVE TITANIUM ABUTMENT BLANK COMPATIBLE WITH: HIOSSEN HG SYSTEM STANDARD. IN THE VIDEO HE DEMONSTRATED THE DIFFERENCE IN FIT BETWEEN OUR ABUTMENT AND THE ACTUAL HIOSSEN ABUTMENT. IN THE DEMONSTRATION THE PROVIDER SAID THAT THERE WAS WIGGLE WHEN ATTEMPTING TO MATE OUR BLANK WITH THE HOISSEN IMPLANT. IN THE RMA NOTES IT STATED THAT THE CUSTOMER HAD AN ISSUE WITH THIS BLANK. THEY ADVISE THE BLANK WAS NOT FULLY ENGAGING AND ROCKING BACK AND FORTH. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5024 INCLUSIVE TITANIUM ABUTMENT INCLUSIVE TITANIUM ABUTMENT BLANK COMPATIBLE WITH: HIOSSEN HG SYSTEM NHA PRISMATIK DENTALCRAFT, INC 70-1147-COM0009 6233949

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown