BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT 03.5 X11.5MM

    MDR report key: 13522652 · Received February 14, 2022

    Report

    Report Number
    3011649314-2022-00021
    Event Type
    Injury
    Date Received
    February 14, 2022
    Date of Event
    December 10, 2021
    Report Date
    June 3, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. IF/WHEN THERE IS MORE INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. HOWEVER, THE NON-VISUAL DEVICE EVALUATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT# 6051418 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 PACKAGED STOCK PRODUCT IS NOT APPLICABLE FOR REVIEW SINCE NO DEFECT COULD BE CONFIRMED. 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: A ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. IT IS UNKNOWN IF THE BREAKAGE WAS A RESULT OF POOR PROSTHETIC DESIGN.

    Additional Manufacturer Narrative · 0

    CAPA (B)(4). MANUFACTURER REFERENCE: COMP (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE BONE GRADE IS NOTED AS GRADE III. THE PATIENT HAS NO MEDICAL OR DENTAL HISTORY NOTED. THE PATIENT PRESENTED ON (B)(6) 2019 FOR IMPLANT PLACEMENT ON TOOTH #5. THE PATIENT RETURNED (B)(6) 2021 NOTING THAT THE IMPLANT BROKE. UPON EXAM, THE PROVIDER CONFIRMS A BROKEN IMPLANT THAT RESULTED IN THE NEED TO REPLACE IT WITH HIOSSEN IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119590 HAHN TAPERED IMPLANT 03.5 X11.5MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0006 6051418

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention