BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETIII SA FIXTURE

    MDR report key: 4336151 · Received November 25, 2014

    Report

    Report Number
    3007135442-2014-00001
    Event Type
    Injury
    Date Received
    November 25, 2014
    Date of Event
    October 16, 2014
    Report Date
    November 14, 2014
    Manufacturer
    HIOSSEN INC.
    Product Code
    DZE
    PMA / PMN Number
    K101096
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS REPORTED TO HIOSSEN INC THAT LOOSENING (FRACTURE) OCCURRED TO FEMALE PATIENT WHO IS IN HE MID 40. THE INVESTIGATION WITH ACTUAL PRODUCT WAS NOT PERFORMED SINCE THE DENTIST REFUSED TO PROVIDE IT TO HIOSSEN INC. THEREFORE, LIMITED INVESTIGATION WAS PERFORMED WITH DEVICE HISTORY RECORDS SUCH AS INCOMING INSPECTION SHEET OF RAW MATERIAL, TITANIUM (GR4), IN-PROCESS, FINAL INSPECTION SHEET, MANUFACTURING BATCH RECORD, ETC. THERE WERE NO DISCREPANCIES FOUND. AN NO SIMILAR ISSUES WERE REPORTED TO HIOSSEN INC. ALSO PRODUCT PICTURES AND X-RAYS WERE SENT TO ONE OF OUR FACULTY DENTIST AS A PART OF INVESTIGATION FOR POSSIBLE CAUSE. HIOSSEN INC CONCLUDES THAT FRACTURE OCCURRED DUE TO THE FOLLOWING REASONS: PHOTOGRAPHIC COMMENTS: AFTER CAREFULLY REVIEW OF THE PHOTOGRAPHS, IT IS ASSUMED THAT THE TOP PORTION OF THE IMPLANT DID NOT FULLY INTEGRATE WITH THE PATIENT'S BONE, AS SHOWN BY THE ABSENCE OF ATTACHED HARD TISSUE AT THE TOP OF THE IMPLANT. ATTACHED HARD TISSUE IS PRESENT CLOSEST TO THE POINT OF FRACTURE. RADIOGRAPHIC COMMENTS: IT IS BELIEVED THAT THE SITE'S SURROUNDING HARD TISSUE WAS IN A POOR STATE (A BUCCAL BONE DEFECT) PRIOR TO TOOTH EXTRACTION (PRE-OP X-RAY). RADIOGRAPHS OF THE PLACEMENT AND HEALING SHOW THAT THE APEX OF THE IMPLANT SUCCESSFULLY INTEGRATED, BUT THE UPPER PORTION STILL LACKED COMPLETE BONE INTEGRATION. FINAL RADIOGRAPH OF THE FRACTURED IMPLANT SEEMED TO SHOW THE POINT OF FRACTURE IS WHERE THE COMPLETE INTEGRATION AND IMPROPER INTEGRATION MEET. POSSIBLE CAUSES OF FIXTURE FRACTURING: IT IS ASSUMED THAT THERE WERE SEVERAL POSSIBILITIES THAT CAUSED THE FRACTURE: INSUFFICIENT CRESTAL HARD TISSUE TO SUPPORT THE UPPER PORTION OF THE IMPLANT FROM MASTICATION AND SHEER FORCE, OVERLOADING OR BRUXISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DENTIST REMOVED AN ENDOSSEOUS DENTAL IMPLANT DUE TO LOOSENING (FRACTURE) THAT WAS NOT CLEAR FOR THE CAUSES. INVESTIGATION WITH ACTUAL PRODUCT HAS NOT BEEN PERFORMED SINCE PRODUCT IS NOT AVAILABLE FOR THE MANUFACTURER. MANY REQUESTS FOR PROVIDING THE PRODUCT WERE DENIED BY DENTIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765655 ETIII SA FIXTURE DENTAL IMPLANT DZE HIOSSEN INC. CET3R4015S H1E11D022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention