BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAHN TAPERED IMPLANT Ø4.3 X 10 MM

    MDR report key: 17651018 · Received August 30, 2023

    Report

    Report Number
    3011649314-2023-00544
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    March 9, 2023
    Report Date
    January 23, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. IF/ WHEN THE DEVICE IS RETURNED AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    DURING DEVICE PLACEMENT, THE IMPLANT DROPPED. THERE WAS NO ALLEGATION OF PATIENT HARM OR PRODUCT MALFUNCTION. 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 HAHN TAPERED IMPLANT LOT# 6130164 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 HAHN TAPERED IMPLANT LOT# 6130164 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS CUSTOMER HAS NOT RETURNED THE REPORTED DEVICE FOR REVIEW. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS I, AND THEIR ORAL HYGIENE IS NOTED AS POOR. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #19. DURING PLACEMENT OF THE DEVICE, THE PROVIDER WAS UNABLE TO ACHIEVE PRIMARY STABILITY, AND THE DEVICE WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE IS I, AND THEIR ORAL HYGIENE IS NOTED AS POOR. THE PATIENT PRESENTED ON (B)(6) 2023 FOR A PRIMARY PROCEDURE ON TOOTH #19. DURING PLACEMENT OF THE DEVICE, THE PROVIDER WAS UNABLE TO ACHIEVE PRIMARY STABILITY, AND THE DEVICE WAS REMOVED. ADDITIONAL INFORMATION RECEIVED VIA QUESTIONNAIRE FROM PROVIDER: THE IMPLANT WAS DROPPED DURING IMPLANT PLACEMENT. THERE IS NO INFORMATION THAT SUGGESTS A CUSTOMER COMPLAINT, SERIOUS INJURY, OR PRODUCT MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493210 HAHN TAPERED IMPLANT Ø4.3 X 10 MM HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0010 6130164

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male