BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONO BENDABLE ONE PIECE IMPLANT

    MDR report key: 19400226 · Received May 27, 2024

    Report

    Report Number
    3011390931-2024-00237
    Event Type
    Injury
    Date Received
    May 27, 2024
    Date of Event
    September 21, 2023
    Report Date
    May 27, 2024
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN COMPLETED, EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF MISSING EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING), AND REASON FOR IMPLANT REMOVAL. THE DHR WAS REVIEWED FOR LOT#7000311, AND NO EVIDENCE WAS DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. TO DATE, ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022. ON (B)(6) 2023, LOOSENING OF IMPLANT WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT OPERATIVE OR POST-OPERATIVE COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237788 MONO BENDABLE ONE PIECE IMPLANT MONO BENDABLE ONE PIECE DENTAL IMPLANT DZE NORIS MEDICAL LTD NMBV3708 7000311

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female