BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø5.0 X 10 MM

    MDR report key: 19644661 · Received July 1, 2024

    Report

    Report Number
    3011649314-2024-00457
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    May 7, 2024
    Report Date
    September 11, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION HAS BEEN COMPLETED; FOLLOWING IS THE DEVICE ANALYSIS CONCLUSION: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT#6120947 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#6120947 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø5.0 X 10 MM (70-1154-IMP0015) USING RADIOGRAPHIC TEMPLATE (PK-209-062515). THERE WAS NO DEFECT OR NON-CONFORMITY OBSERVED AND THE THREADS WERE INTACT. MATTER WAS OBSERVED IN THE THREADING OF THE IMPLANT. (SEE ATTACHED IMAGES). THE COMPLAINT IS VERIFIED BASED ON THE RETURNED PART(S) BUT CANNOT CONFIRM THE FAILURE MODE. THERE WAS NO EVIDENCE FOUND THAT INDICATED THAT THE REPORTED ISSUE WAS CAUSED BY THE DEVICE ITSELF. 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. IT IS UNCLEAR THE METHODS OF IMPLANT PLACEMENT USED DURING THE INITIAL PROCEDURE OR IF APPROPRIATE LOAD DISTRIBUTION WAS OBSERVED. IFU 570 REV 3.0 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE IMPLANT PLACEMENT SECTION: "STEP 2: INITIAL PLACEMENT - ENGAGE THE IMPLANT CONNECTION WITH THE APPROPRIATE DRIVER. WITH THE IMPLANT SECURELY ATTACHED TO THE DRIVER, 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. STEP 3: 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." IFU 570 REV 3.0 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN THE METHODS OF IMPLANT PLACEMENT SECTION: "OPTION 1: HANDPIECE IMPLANT PLACEMENT - PLACE THE APPROPRIATE IMPLANT DRIVER INTO THE HANDPIECE. SEAT THE DRIVER INTO THE INTERNAL HEX CONNECTION OF THE IMPLANT, AND PRESS FIRMLY TO FULLY ENGAGE THE CONNECTION. THREAD THE IMPLANT INTO THE OSTEOTOMY AT APPROXIMATELY 25 RPM UNTIL FULLY SEATED. OPTION 2: MANUAL IMPLANT PLACEMENT - ASSEMBLE THE ADJUSTABLE TORQUE WRENCH WITH THE SURGICAL ADAPTOR AND APPROPRIATE IMPLANT DRIVER. WITH THE IMPLANT THREADED SECURELY IN ITS SITE, SEAT THE DRIVER INTO THE INTERNAL HEX CONNECTION OF THE IMPLANT, AND PRESS FIRMLY TO FULLY ENGAGE THE CONNECTION. TURN THE WRENCH CLOCKWISE IN INCREMENTS OF APPROXIMATELY 90 DEGREES. AVOID LATERAL FORCES, WHICH CAN AFFECT FINAL ALIGNMENT OF THE IMPLANT." MANUFACTURER'S INTERNAL REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAHN TAPERED IMPLANT FAILED. NO RELEVANT MEDICAL OR DENTAL HISTORY OF THE PATIENT WAS REPORTED. ON (B)(6) 2024, THE PATIENT PRESENTED FOR A PRIMARY PROCEDURE ON TOOTH #17. DURING IMPLANT PLACEMENT THE PROVIDER COULD NOT FIT THE DRIVER INTO THE IMPLANT HEAD AND THEREFORE EXPLANTED THE DEVICE. THE IMPLANT WAS REPLACED, AND NO FURTHER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616675 HAHN TAPERED IMPLANT Ø5.0 X 10 MM HAHN TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0015 6120947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention