BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21868703 · Received April 18, 2025

    Report

    Report Number
    3011649314-2025-00326
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Report Date
    October 18, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

    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. 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 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 THERE WAS NO STOCK PRODUCT FROM LOT#6032872 AVAILABLE FOR REVIEW. TS - 10/17/2025 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 A FRACTURE AT THE NECK OF THE IMPLANT ON TOOTH LOCATION 24. THE PATIENT UNDERWENT THE PLACEMENT OF 5 UPPER IMPLANTS IN (B)(6) 2018, FOLLOWING A PERIODONTAL TREATMENT FOR DISEASE. PER THE REPORT THE PATIENT CALLED AND THREATENED TO SUE THE HEALTHCARE PROFESSIONAL BECAUSE THEY HAD LOST TWO IMPLANTS. THE PATIENT WAS IMMEDIATELY REFERRED TO A REHABILITATION SPECIALIST. IT WAS REPORTED THAT THE REHABILITATION SPECIALIST CONFIRMED A FRACTURE AT THE NECK OF THE IMPLANT ON LOCATION 24 AND THEY ALSO PROVIDED THE HEALTHCARE PROFESSIONAL PHOTOGRAPHS AND AN X-RAY. THE REHABILITATION SPECIALIST STATED THAT THE CROWN ON TOOTH 25 ONLY NEEDED TO BE SCREWED IN AND THEY ALSO CONFIRMED THAT THE 5 SCREW-RETAINED CROWNS HAD BEEN PLACED WITH COMPONENTS SUPPLIED AND PURCHASED FROM THE REPRESENTATION IN COLOMBIA AT THE TIME, DR. (B)(6). PER THE REPORT THE PATIENT DID NOT ATTEND ANY PERIODONTAL FOLLOW-UPS WITH THE HEALTHCARE PROFESSIONAL AFTER THE IMPLANT PLACEMENT. IT WAS ALSO STATED THAT THE OSSEOINTEGRATION IS SATISFACTORY AFTER 7 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776503 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 61 YR Male