BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETIII SA FIXTURE

    MDR report key: 8821636 · Received July 24, 2019

    Report

    Report Number
    3007135442-2019-00003
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    March 30, 2019
    Report Date
    May 24, 2019
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    PMA / PMN Number
    K151626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    HIOSSEN PERFORMED AN EXTENSIVE DOCUMENT REVIEW OF THE LOT# H1E13K012 - DEVICE HISTORY RECORD, MANUFACTURING BATCH RECORD, INSPECTION RECORD, RAW MATERIAL RECORD AND RETURNS RECORD. ALL RECORDS SHOW THAT THE LOT WAS MANUFACTURED WITHIN SPECIFICATIONS. RETURN RECORDS SHOW THAT NO OTHER FRACTURE CASES WERE REPORTED. SINCE THE DEVICE WAS RETURNED, A THROUGH EXTERNAL EXAMINATION OF THE IMPLANT WAS PERFORMED, USING A MICROSCOPE AND MINI SEM. WHAT WAS OBSERVED WAS A) TOP PORTION OF THE IMPLANT WAS "CLEAN" (NO HARD TISSUE WAS PRESENT). IT WAS OBSERVED THE INTERNAL HEX WAS DAMAGED AND THE POINT OF BREAKAGE THERE WAS A VERTICAL FISSURE/CRACK. THE PATIENT CHART WAS NOT PROVIDED AND A REVIEW OF THE CASE AND PATIENT'S MEDICAL HISTORY WAS NOT POSSIBLE. HIOSSEN'S CONCLUSION BASED ON THE EVALUATION OF THE DEVICE WAS THE FRACTURE WAS DUE TO A LOSS OF STRUCTURALLY INTEGRITY. THE ROOT CAUSE OF THE FRACTURE COULD NOT BE DEFINITIVELY DETERMINED DUE TO THE LACK OF INFORMATION (PATIENT CHART, MEDICAL HISTORY, ABUTMENT, CROWN). THERE ARE SEVERAL FACTORS THAT CAN CONTRIBUTE TO CAUSING A FRACTURE: BONE LOSS (WHICH CAN BE ATTRIBUTED TO POOR ORAL HYGIENE OR PERIODONTAL DISEASE) WHICH, SIGNIFICANTLY REDUCES THE FATIGUE LIFE OF THE IMPLANT, IMPROPER PROSTHETIC DESIGN (OVER CANTILEVER), IMPROPER ENGAGEMENT OF ABUTMENT AND FIXTURE, MIS-MATCHING ABUTMENT INTERNAL CONNECT WITH FIXTURE, USING UNAUTHORIZED PROSTHETIC PARTS, UNDER OR OVER TORQUING ABUTMENT SCREW, NO RE-TIGHTENING OF ABUTMENT SCREW. (B)(4).

    Description of Event or Problem · 1

    PRODUCT COMPLAINT ALONG WITH DENTAL IMPLANT WAS SUBMITTED (OTHER COMPONENTS WERE NOT SENT). NO PATIENT CHART OR MEDICAL HISTORY WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615747 ETIII SA FIXTURE DENTAL IMPLANT DZE HIOSSEN, INC. AET3R4008B H1E16K255

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention