BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLUSIVE TAPERED IMPLANT 3.2 MMD X 11.5 MML X 3.0 MMP

    MDR report key: 22401038 · Received July 3, 2025

    Report

    Report Number
    3011649314-2025-00669
    Event Type
    Injury
    Date Received
    July 3, 2025
    Date of Event
    May 28, 2025
    Report Date
    December 15, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K121406
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: COMP-(B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION HAS BEEN COMPLETED; FOLLOWING IS THE DEVICE ANALYSIS CONCLUSION: DHR RESULTS: THE DHR WAS REVIEWED FOR LOT# 6140224 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#6140224 AVAILABLE FOR REVIEW. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE AN INCLUSIVE TAPERED IMPLANT 3.2 MMD X 11.5 MML X 3.0 MMP (70-1070-IMP0032) USING RADIOGRAPHIC TEMPLATE (GD-437-091015). 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 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 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. PER THE REPORTED INFORMATION, IT WAS MENTIONED THE ABUTMENT HAD A FIT ISSUE. FIT ISSUE WAS DUE TO SOMETHING OBSTRUCTING THE IMPLANT. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THERE WAS A FRACTURED COMPONENT INSIDE AN INCLUSIVE TAPERED IMPLANT AND THE HEALING ABUTMENT WOULD NOT THREAD IN, SOMETHING OBSTRUCTED THE INTERNAL THREADING OF THE IMPLANT. THE IMPLANT APPEARED TO BE THE CAUSE AND CAME IN THE BOX LIKE THIS. A PHOTOGRAPH WAS PROVIDED SHOWING THE LEFT IMAGE BEING THE INITIAL IMPLANT, IN WHICH A BRAND-NEW HEALING ABUTMENT WOULD NOT THREAD INTO IT. THE IMPLANT WAS REMOVED AND REPLACED WITH AN IDENTICAL SIZE AND THE HEALING ABUTMENT. PER THE REPORT THE PATIENT DID NOT EXPERIENCE PERMANENT INJURY NOR WERE ADDITIONAL PROCEDURES PERFORMED. IT WAS REPORTED THAT AT THE TIME OF THE SURGICAL PROCEDURE THE PATIENT'S BONE QUALITY WAS TYPE I WITH EXCELLENT ORAL HYGIENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484109 INCLUSIVE TAPERED IMPLANT 3.2 MMD X 11.5 MML X 3.0 MMP INCLUSIVE TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1070-IMP0032 6140224

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention