BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAHN TAPERED IMPLANT Ø3.5 X 10 MM

    MDR report key: 18727541 · Received February 16, 2024

    Report

    Report Number
    3011649314-2024-00121
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 2, 2024
    Report Date
    May 19, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SAMPLE DEVICE WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. SHOULD THE DEVICE BE RETURNED, AN INVESTIGATION WILL BE COMPLETED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B2, G1 (EMAIL AND FAX), H6 (TYPE OF THE INVESTIGATION). CORRECTED INFORMATION G1 (ADDRESS), H1, H6. CUSTOMER WILL NOT RETURN THE REPORTED DEVICE AS IT IS STILL IMPLANTED. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. DHR RESULTS THE DHR WAS REVIEWED FOR LOT#6122033 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#6122033 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS CUSTOMER WILL NOT RETURN THE REPORTED DEVICE AS IT IS STILL IMPLANTED IN THE PATIENT. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE 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 3 (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. CAPA CA-00016. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE HAHN TAPERED IMPLANT FAILED ON TOOTH #30. NO MEDICAL HISTORY REPORTED. THE PATIENT'S BONE QUALITY IS TYPE I AND THE PATIENT'S ORAL HYGIENE STATUS IS GOOD. UPON EXAMINATION AFTER THE FINAL PROSTHESIS DELIVERY THE PROVIDER NOTICED THAT THE IMPLANT HAD FRACTURED. THE DEVICE WAS NOT REMOVED, AND A SECOND IMPLANT WAS PLACED NEXT TO THE FRACTURED ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432805 HAHN TAPERED IMPLANT Ø3.5 X 10 MM HAHN TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0005 6122033

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention