BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORIS MEDICAL ZYGOMATIC DENTAL IMPLANT

    MDR report key: 18282907 · Received December 6, 2023

    Report

    Report Number
    MW5148942
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    October 2, 2023
    Report Date
    December 4, 2023
    Manufacturer
    NORIS MEDICAL LTD.
    Product Code
    NHA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NORIS MEDICAL MAKES ZYGOMATIC IMPLANTS THAT ARE NOT PACKAGED CORRECTLY AND THAT THEY DO NOT INSERT CORRECTLY WITH THE PROTOCOL DESCRIBED. PLEASE CHECK ALL IMPLANTS THAT ARE MADE. THE CARRIER BREAKS IN THE IMPLANT DURING PLACEMENT. COMPANY REFUSES TO STAND BY THEIR PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365538 NORIS MEDICAL ZYGOMATIC DENTAL IMPLANT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA NORIS MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Prefer Not To Disclose Other