BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT

    MDR report key: 20100123 · Received August 29, 2024

    Report

    Report Number
    3011649314-2024-00689
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    April 17, 2023
    Report Date
    October 17, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: THE MODEL #, CATALOG #, LOT #, EXPIRATION DATE, AND UDI INFORMATION WAS REQUESTED BUT WERE NOT AVAILABLE. H4: MANUFACTURE DATE IS NOT AVAILABLE AS THE LOT # COULD NOT BE PROVIDED. 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. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS PER THE REPORTED INFORMATION, THE LOT NUMBER PROVIDED WAS LOT# 6111685. HOWEVER, LOT# 6111685 IS FOR A HAHN TAPERED IMPLANT HEALING ABUTMENT AND NOT FOR THE IMPLANT ITSELF. THE LOT NUMBER WAS NOT PROVIDED FOR THE HAHN TAPERED IMPLANT THEREFORE THE DHR COULD NOT BE REVIEWED. STOCK PRODUCT REVIEWED RESULTS PER THE REPORTED INFORMATION, THE LOT NUMBER PROVIDED WAS LOT# 6111685. HOWEVER, LOT# 6111685 IS FOR A HAHN TAPERED IMPLANT HEALING ABUTMENT AND NOT FOR THE IMPLANT ITSELF. THE LOT NUMBER WAS NOT PROVIDED FOR THE HAHN TAPERED IMPLANT THEREFORE THE STOCK PRODUCT COULD NOT BE REVIEWED. INVESTIGATION METHODS/RESULTS PER THE REPORTED INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED AND IT IS UNKNOWN IF THE DEVICE WAS RETURNED. TO DATE, THE DEVICE HAS NOT BEEN PHYSICALLY ACCOUNTED FOR AND SENT TO THE COMPLAINT'S TEAM FOR ANALYSIS. ROOT CAUSE DESCRIPTION ADDITIONAL INFORMATION ON THE TYPE OF FAILURE WAS NOT PROVIDED THEREFORE THE ROOT CAUSE COULD NOT BE DETERMINED. CORRECTIVE ACTION ADDITIONAL INFORMATION ON THE TYPE OF FAILURE WAS NOT PROVIDED THEREFORE THE CORRECTIVE ACTION CAUSE COULD NOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING THE EXPLANT OF A DEVICE ON TOOTH # 9 ON (B)(6) 2023, A REPLACEMENT DEVICE WAS IMPLANTED THE SAME DAY. AT A FOLLOW-UP VISIT, THE PROVIDER DETERMINED THAT THE IMPLANT FAILED AND THE DEVICE WAS EXPLANTED. NO ADDITIONAL INFORMATION REGARDING THE TYPE OF FAILURE OR PATIENT SYMPTOMS WERE REPORTED OR AVAILABLE. THE DEVICE DISPOSITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354674 HAHN TAPERED IMPLANT HAHN TAPERED IMPLANT DZE PRISMATIK DENTALCRAFT, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention