BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETIII SA FIXTURE

    MDR report key: 7736725 · Received July 31, 2018

    Report

    Report Number
    3007135442-2018-00001
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    May 22, 2018
    Report Date
    July 31, 2018
    Manufacturer
    HIOSSEN, INC.
    Product Code
    DZE
    UDI-DI
    00814913021041
    PMA / PMN Number
    K140934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    HIOSSEN PERFORMED AN EXTENSIVE DOCUMENT REVIEW OF LOT# H1E12G070 - DEVICE HISTORY RECORD, MANUFACTURING BATCH RECORD, INSPECTION RECORD, RAW MATERIAL RECORD AND RETURNS RECORD. ALL RECORDS SHOW THAT THE LOT WAS MANUFACTURED WITH IN SPECIFICATIONS. RETURN RECORDS SHOW THAT NO FRACTURE CASES WERE REPORTED. SINCE THE DEVICE WAS RETURNED, A THROUGH INSPECTION USING HIGH POWERED MICROSCOPE AND MINI SEM WAS PERFORMED. IT WAS DETERMINED THAT THE INTERNAL HEX RECEIVED DAMAGE AND IS A POSSIBLE POINT OF WEAKENING. FINALLY, HIOSSEN REVIEWED THE PATIENT'S RECORDS AND X-RAYS. ACCORDING TO THE X-RAYS, THE IMPLANT SITE SUFFERED BONE LOSS ABOUT 2 YEARS AND 6 MONTHS AFTER IMPLANTATION, BUT NO REMEDIATION OR TREATMENT WAS PERFORMED. HIOSSEN'S CONCLUSION BASED ON THE INFORMATION COLLECTED IS THAT THE DAMAGED INTERNAL HEX REDUCED THE IMPLANT'S STRUCTURAL INTEGRITY BUT THIS ALONE WOULD NOT FRACTURE THE IMPLANT. SINCE BONE LOSS WAS OBSERVED, THE SUPPORT TO THE IMPLANT WAS SLOWLY DISAPPEARING AND THUS METAL FATIQUE EXPONENTIALLY INCREASE RESULTING IN THE FRACTURE.

    Description of Event or Problem · 1

    ON (B)(6) 2018, (B)(6) HAD HIS TOOTH #9 DENTAL IMPLANT REMOVED AFTER 3 YEARS AND 4 MONTHS OF IMPLANTATION. ACCORDING TO THE PATIENT'S CHART, ON (B)(6) 2018 THE CROWN AND ABUTMENT WAS DISASSEMBLED AND THE PROSTHODONTIST DISCOVERED THE IMPLANT WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579503 ETIII SA FIXTURE DENTAL IMPLANT DZE HIOSSEN, INC. CET3R4011S H1E12G070 00814913021041

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention