BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAHN TAPERED IMPLANT SURGICAL KIT

    MDR report key: 16133308 · Received January 10, 2023

    Report

    Report Number
    3011649314-2022-00744
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    September 15, 2022
    Report Date
    May 15, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PATIENT'S WEIGHT WAS ASKED BUT NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. HOWEVER, THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT# 6120942 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# 6120942 AVAILABLE FOR REVIEW. 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: A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. PROBABLE ROOT CAUSE IS IMPROPER SEATING OF THE IMPLANT DRIVER INTO THE INTERNAL HEX OF THE IMPLANT. ADDITIONALLY, IT IS UNCLEAR THE METHODS OF IMPLANT PLACEMENT USED DURING THE INITIAL PROCEDURE OR IF APPROPRIATE LOAD DISTRIBUTION WAS OBSERVED. PER IFU- 570 REV 4.0 (HAHN TAPERED IMPLANT SYSTEM IFU), THE "IMPLANT PLACEMENT" SECTION STATES: "USE SLIGHT FINGER PRESSURE TO PINCH THE OCCLUSAL END OF THE IMPLANT IN ITS HOLDER WHILE INSERTING THE APPROPRIATE IMPLANT DRIVER. GENTLY ROTATE IMPLANT AND HOLDER, ALLOWING THE DRIVER TO ENGAGE THE IMPLANT CONNECTION. WITH THE DRIVER SECURELY ATTACHED TO THE IMPLANT, SQUEEZE THE OPPOSING END OF THE HOLDER TO DISENGAGE THE IMPLANT FROM THE HOLDER. TRANSPORT THE IMPLANT TO THE PREPARED SITE, AND INSERT INTO THE OSTEOTOMY. ROTATE CLOCKWISE WITH APPLIED PRESSURE TO ENGAGE THE SELF-TAPPING GROOVES. AVOID LATERAL FORCES, WHICH CAN AFFECT THE ANGULATION AND FINAL ALIGNMENT OF THE IMPLANT. ADVANCEMENT AND FINAL SEATING - CONTINUE THREADING THE IMPLANT INTO THE OSTEOTOMY SITE USING THE PREFERRED PLACEMENT METHOD. A MINIMUM TORQUE VALUE OF 35 NCM UPON FINAL SEATING INDICATES GOOD PRIMARY STABILITY. · THIS COMPLAINT WILL BE KEPT ON RECORD FOR TRACK AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    NOTE: D4 CHANGED FROM 6120942 TO UNKNOWN FOR THE LOT NUMBER. CAPA 23-006. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION: CORRECTED B4 TO INCLUDE THE ORIGINAL DATE OF THE REPORT OF 01-10-2023, AS IT WAS ENTERED INCORRECTLY ON THE INITIAL SUBMISSION.

    Additional Manufacturer Narrative · 0

    NOTE: THIS COMPLAINT IS RELATED TO A SURGICAL KIT THEREFORE D6A, D6B AND H6 - 4627 SHOULD NOT HAVE BEEN REPORTED IN THE INITIAL REPORT. CAPA: CA-00016 MANUFACTURER REFERENCE: COMP-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. THE PATIENT'S BONE TYPE RANGES BETWEEN III AND IV. THE PATIENT'S HYGIENE IS LISTED AS FAIR. THE PATIENT HAS A HISTORY OF DIABETES, PERIODONTITIS, AND BRUXISM. THE PATIENT PRESENTED ON (B)(6)2022 FOR A PRIMARY PROCEDURE ON TOOTH #31. DURING IMPLANT PLACEMENT, THE PROVIDER WAS UNABLE TO FIT THE HANDPIECE THROUGH THE SURGICAL GUIDE.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS OPENED TO ADDRESS THE REPORTED ISSUE OF THE HAHN TAPERED IMPLANT SURGICAL KIT. THE PROVIDER WAS UNABLE TO FIT THE HANDPIECE THROUGH THE SURGICAL GUIDE FOR TOOTH #31 AND UNABLE TO PLACE IMPLANTS TO DEPTH FOR TOOTH #26 AND #30. FOR TOOTH #30 THE PROVIDER WAS UNABLE TO TORQUE THE IMPLANT OUT WITH THE SURGICAL GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195294 HAHN TAPERED IMPLANT SURGICAL KIT SURGICAL KIT DZE PRISMATIK DENTALCRAFT, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male