BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN IMPLANT HAHN TAPERED IMPLANT Ø3.5 X 11.5 MMX 11.5

    MDR report key: 21868344 · Received April 18, 2025

    Report

    Report Number
    3011649314-2025-00325
    Event Type
    Injury
    Date Received
    April 18, 2025
    Date of Event
    March 8, 2025
    Report Date
    October 18, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT INFORMATION WAS RECEIVED. D1 - BRAND NAME. D4 - MODEL #, CATALOG #, LOT #, EXPIRATION DATE, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) #. H4 - DEVICE MANUFACTURE DATE. (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. SHOULD ADDITIONAL INFORMATION BE PROVIDED BY THE CUSTOMER A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE ADDITIONAL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE PROBABLE ROOT CAUSE OF THE EVENT HAS NOT BEEN IDENTIFIED. SHOULD THE DEVICE BE RETURNED, AN INVESTIGATION WILL BE CONDUCTED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSION. IT WAS STATED THAT THE HEALTHCARE PROFESSIONAL PROVIDED PERIODONTAL CLINICAL HISTORY, IMPLANT STICKER, AND A POSTERIOR X-RAY; HOWEVER, WE HAVE NOT RECEIVED THAT INFORMATION FROM THE COLOMBIA TEAM. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR HAHN TAPERED IMPLANT LOT# 6032872 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# 6032872 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. 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 DESCRIPTION: THE ROOT CAUSE WAS INCONCLUSIVE AND CANNOT BE EXPLICITLY DETERMINED. THE PROBABLE CAUSE FOR THE FRACTURE COULD BE CONTRIBUTED BY USER/PATIENT FACTORS. IFU-570 REV 7 (HAHN TAPERED IMPLANT SYSTEM IFU). FOR BEST RESULTS, PLEASE OBSERVE THE FOLLOWING PRECAUTIONS: ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL, COPIOUS IRRIGATION. ALL SURGICAL INSTRUMENTS USED MUST BE IN GOOD CONDITION AND SHOULD BE USED CAREFULLY TO AVOID DAMAGE TO IMPLANTS OR OTHER COMPONENTS. IMPLANTS SHOULD BE PLACED WITH SUFFICIENT STABILITY; HOWEVER, EXCESSIVE INSERTION TORQUE MAY RESULT IN IMPLANT FRACTURE, OR FRACTURE OR NECROSIS OF THE IMPLANT SITE. THE PROPER SURGICAL PROTOCOL SHOULD BE STRICTLY ADHERED TO. SINCE IMPLANT COMPONENTS AND THEIR INSTRUMENTS ARE VERY SMALL, PRECAUTIONS SHOULD BE TAKEN TO ENSURE THAT THEY ARE NOT SWALLOWED OR ASPIRATED BY THE PATIENT. PRIOR TO SURGERY, ENSURE THAT THE NEEDED COMPONENTS, INSTRUMENTS, AND ANCILLARY MATERIALS ARE COMPLETE, FUNCTIONAL AND AVAILABLE IN THE CORRECT QUANTITIES. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED A HAHN TAPERED IMPLANT EXHIBITED METAL FATIGUE AND CROWN MOBILITY 7 YEARS AFTER IMPLANT PLACEMENT. IT WAS REPORTED THAT THE PATIENT WENT TO THE HEALTHCARE PROFESSIONAL AND REPORTED DISCOMFORT DUE TO CROWN MOBILITY. UPON REMOVING THE CROWN, THE HEALTHCARE PROFESSIONAL VERIFIED THAT IT HAD A FRACTURE ON THE NECK OF THE IMPLANT. IT WAS REPORTED THAT THE OSSEOINTEGRATION OF THE IMPLANT WAS INTACT. PER THE REPORT THE PATIENT WAS REHABILITATED WITH A BRUXIS CROWN FROM THE GLIDEWELL LABORATORY IN BOGOTÁ, USING HAHN ATTACHMENTS. THE DOCTOR STATED THEY PLACED THE CROWN THEMSELVES. IT WAS REPORTED THAT THE PATIENT IS A REGULAR PERIODONTAL PATIENT, ATTENDING ANNUAL PERIODONTAL MAINTENANCE APPOINTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775418 HAHN IMPLANT HAHN TAPERED IMPLANT Ø3.5 X 11.5 MMX 11.5 HAHN TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC 70-1154-IMP0006 6032872

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other