BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT GUIDED SURGICAL KIT

    MDR report key: 21849553 · Received April 16, 2025

    Report

    Report Number
    3011649314-2025-00324
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    March 1, 2025
    Report Date
    October 18, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    NDP
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE EVALUATION IS PENDING. AT THE COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE ANALYSIS CONCLUSION. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED; DOCUMENTATION INDICATES THE PRODUCT MET RELEASE CRITERIA. THE PROBABLE ROOT CAUSE OF THE EVENT HAS NOT YET BEEN IDENTIFIED. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4). THE PATIENT'S ETHNICITY/RACE WAS REPORTED AS ASIAN BY THE HEALTHCARE PROFESSIONAL.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT#6132359 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 LOT# 6132359 AND FOUND NO ADDITIONAL PRODUCT IN STOCK. INVESTIGATION METHODS/RESULTS: THE REPORTED PRODUCT WAS RETURNED, BUT NOT IN THE ORIGINAL PACKAGING. IT WAS OBSERVED THAT THE TIP OF THE DRIVER WAS FRACTURED. ROOT CAUSE DESCRIPTION: A ROOT CAUSE FOR THIS COMPLAINT CANNOT BE EXPLICITLY DETERMINED. PROBABLE ROOT CAUSE IS THE OVER-TORQUING OF THE DRIVER DURING THE IMPLANT PLACEMENT WHICH MAY HAVE CAUSED A FRACTURE. ADDITIONALLY, IT IS UNCLEAR THE METHODS OF IMPLANT PLACEMENT USED DURING THE PROCEDURE AND THE INSERTION TORQUE VALUE. IFU 570 REV 3 (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 (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 REFERENCE: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED A HAHN TAPERED IMPLANT WAS REMOVED DUE TO THE HAHN IMPLANT DRIVER FRACTURING INSIDE THE IMPLANT DURING IMPLANT PLACEMENT. IT WAS REPORTED THAT THE TIP OF THE IMPLANT BROKE OFF INSIDE THE IMPLANT DURING IMPLANT PLACEMENT ON TOOTH NUMBER 21; IT WAS STATED BY THE HEALTHCARE PROFESSIONAL THAT THIS INSTRUMENT FRACTURE WAS THE REASON THE IMPLANT HAD TO BE REMOVED AND REPLACED. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER DID NOT OBSERVE ANY PATIENT SYMPTOMS OR PERMANENT INJURY. PER THE REPORT THE DEVICE WAS REMOVED, AND IT WAS REPLACED WITH A PRODUCT SIMILAR TO THE COMPLAINT PRODUCT AND NO ADDITIONAL PROCEDURES WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127111 HAHN TAPERED IMPLANT GUIDED SURGICAL KIT IMPLANT DRIVER NDP PRISMATIK DENTALCRAFT, INC. 70-1071-SRG0230 6132359

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention HAHN TAPERED IMPLANT Ø3.5 X 10 MM, 6131049.