BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM

    MDR report key: 19607794 · Received June 25, 2024

    Report

    Report Number
    3011649314-2024-00429
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 30, 2024
    Report Date
    September 12, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K143353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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#6200495 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: THE STOCK PRODUCT FOR HT IMPLANT LOT#6200495 IS NOT APPLICABLE FOR REVIEW SINCE THE ISSUE IS CUSTOMER RELATED. INVESTIGATION METHODS/RESULTS: THE DEVICE WAS RETURNED BUT NOT IN ORIGINAL PACKAGE. THE IMPLANT WAS VERIFIED TO BE A HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM (70-1154-IMP0006) 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 COULD NOT BE VERIFIED BASED ON THE RETURNED PART(S) AND 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 CANNOT BE EXPLICITLY DETERMINED. IT IS UNKNOWN OF THE CUSTOMER FOLLOWED INSTRUCTIONS IN IFU-570. IFU-570 REV 4.0 (HAHN TAPERED IMPLANT SYSTEM) CONTAINS THE FOLLOWING STATEMENT IN PRECAUTION SECTION SURGICAL PROCEDURES: "MINIMIZING TISSUE DAMAGE IS CRUCIAL TO SUCCESSFUL IMPLANT OSSEOINTEGRATION. IN PARTICULAR, CARE SHOULD BE TAKEN TO ELIMINATE SOURCES OF INFECTION, CONTAMINANTS, SURGICAL AND THERMAL TRAUMA. RISK OF OSSEOINTEGRATION FAILURE INCREASES AS TISSUE TRAUMA INCREASES. ALL DRILLING PROCEDURES SHOULD BE PERFORMED AT 2000 RPM OR LESS UNDER CONTINUAL AND 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."

    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) . RELATED TO MANUFACTURER REPORT NUMBER: 3011649314-2024-00432.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED A HAHN TAPERED IMPLANT FRACTURED DURING IMPLANT PLACEMENT ON TOOTH NUMBER 4. IT WAS REPORTED THAT AFTER ONE HOUR OF PLACEMENT THE POSTOPERATIVE DENTAL CONE BEAM COMPUTED TOMOGRAPHY (X-RAY) REVEALED WHAT APPEARED TO BE A HORIZONTAL FRACTURE IN THE MIDDLE THIRD PART OF THE IMPLANT. PER THE REPORT DURING REMOVAL THE HEALING ABUTMENT WOULD NOT COME OFF, BUT IT DID COME OFF FULLY INTACT ALONG WITH THE IMPLANT, IT WAS ALL SUCCESSFULLY REMOVED. IT WAS REPORTED THAT THE HEALTHCARE PROVIDER DID NOT OBSERVE ANY PATIENT SYMPTOMS OR PERMANENT INJURY. THE DEVICE WAS REMOVED AND WAS REPLACED WITH A SIMILAR PRODUCT AS THE COMPLAINT PRODUCT AND NO ADDITIONAL PROCEDURES WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448201 HAHN TAPERED IMPLANT Ø3.5 X 11.5 MM HAHN TAPERED IMPLANT SYSTEM DZE PRISMATIK DENTALCRAFT, INC. 70-1154-IMP0006 6200495

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention