BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YXOSS CBR

    MDR report key: 16040162 · Received December 22, 2022

    Report

    Report Number
    3017734069-2022-00001
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 20, 2022
    Manufacturer
    REOSS GMBH
    Product Code
    JEY
    PMA / PMN Number
    K192747
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REOSS GMBH PRODUCED TITANIUM MESH FOR BONE AUGMENTATION IN THE JAW REGION. EACH MESH IS DESIGNED ACCORDING TO THE CUSTOMER`S SPECIFIC NEEDS BASED ON CBCT IMAGES. IN THIS CASE, THE DESIGNER TURNED THE JAW TO THE WRONG SIDE IN OUR DESIGN PROGRAM AND CREATED THE MESH FOR TEETH 29,30 INSTEAD OF 19,20. (THERE WERE LARGE DEFECT REGIONS ON BOTH SIDES OF THE PATIENT, WHICH HELPED THE MIX-UP. AFTER THE 3D DESIGN OF THE MESH IS READY, IT IS SENT TO THE DOCTOR. HE CAN MAKE CHANGES OR IF THE DESIGN FITS, HE MUST APPROVE THE DESIGN. THE DOCTOR ALSO DID NOT REALIZE IT WAS THE WRONG SIDE WHEN REVIEWING THE DESIGN AND APPROVED. DURING THE SURGERY, WHEN HE WAS GOING TO PUT THE MESH IN, HE REALIZED IT DID NOT FIT. HE WAS TRYING TO GET THE MESH TO FIT FROM EVERY ANGLE POSSIBLE. DURING THIS MANIPULIATION HE DAMAGED THE TOOTH 21. HE THEREAFTER MADE THE DECISION TO REMOVE AND GRAFT INTRAOPERATIVELY WITH THE PATIENT'S CONSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050817 YXOSS CBR TITANMESH JEY REOSS GMBH C8742A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Other