CUSTOM MADE GRAFT FOR RECONSTRUCTIVE SURGERY

Dear Doctor, we sincerely thank you for your interest in our custom made graft. As you requested, here you can find detailed information about SmartBone® On DemandTM procedure. What is SMARTBONE® ON DEMAND™? SmartBone® On Demand™ is a service provided by Industrie Biomediche Insubri SA according to the Medical Device Regulation 2017/745 regarding custom-made medical devices, and following three different ways, described in the next page. Step 1 Take a CT Scan in DICOM format of the Patient concentrating on the defect. Please check on our website the guidelines. Step 2 Send the CT Scan to IBI-SA...

If you choose to send us the patient’s DICOM file, together with his clinical prescription, IBI is able to plan the custommade piece. Figure 1 : Design Software You can choose to send us the stereolithographic model directly, reproducing a plastic model of the missing piece of bone (usually the doctors rely on an external laboratory). IBI can use the stereolithographic model to reconstruct the custom-made piece, by previous HD scan. Figure 2 : Stereolithographic mode If you send the design file (.STL), IBI can produce directly the piece, without additional costs. Figure 3 : .STL model, output...

Request HOW TO ORDER A SMARTBONE® ON DEMAND™? You need to send your request to [email protected], adding patient’s and doctor’s name/ surname and a brief description of the clinical case. If the .STL file is not available, please send the DICOM file for our feasibility evaluation. In case of a positive evaluation, IBI’s staff promptly generates a univocal identification code. The formal request for custom made grafts MUST be signed, dated and on the doctor’s letterhead; patient’s name and clinical needs must be indicated. You can find the request form on our website. Request form for...

Order confirmation After the technical approval, IBI will send a form that must be completed in its entirety and then signed in order to proceed with the production order. Producibility confirmation under doctor responsibility Dear Dr. REQUESTING DOCTOR Structure, address Mezzovico-Vira, DATA Re: offer for bone substitutes tailored for case IBI-OD-ID NUMBER Dear Dr. REQUESTING DOCTOR, Upon your request submitted on DATE, we hereby confirm that your order has been taken in charge by our company and was assigned the unique case code IBI-OD-ID NUMBER. Please always refer to this code in any further...

Sending the DICOM file HOW TO SEND US THE DICOM FILE? You can send the DICOM files using an online file-transferring platform such as https://wetransfer. com You can upload your file just adding [email protected] as the receiver’s email address your email address and a brief description of the type of intervention you need from us As soon as we get the file, we make an offer on the basis of the estimated graft volume. Once you accept the offer, we get in touch within 72h to start the design project of the custom made graft together, that will end only once you approve it. After completing...

Clinical Cases design Hereunder you can find some grafts of clinical cases designed with SmartBone® On Demand™. Vertical and horizontal maxillary augmentation J-shape reconstruction for vertical and horizontal mandibular augmentation Courtesy of Dr. R. Ghiretti, Private Dentistry Practice, Mantova J-shape reconstruction for vertical and horizontal mandibular augmentation Vertical and horizontal maxillary augmentation Courtesy of Dr.Norman Ling Courtesy of Dr. R. Ghiretti, Private Dentistry Practice, Mantova

Zygomatzic reconstruction with 3 grafts Courtesy of Prof. Dr. P. Cascone / Dr. V. Ramieri, Policlinico Umberto I, Roma 8 Zygomatic, crestal and hemipalatin reconstruction with 4 grafts Courtesy of Prof. Dr. M. Innocenti / Dr. M. Squadrelli, Azienda Ospedaliera Universitaria, Firenze Mandibular reconstruction Mandibular reconstruction Courtesy of Prof. Dr. P. Cascone / Dr. V. Ramieri, Policlinico Umberto I, Roma Courtesy of Prof. Dr. P. Cascone / Dr. V. Ramieri, Policlinico Umberto I, Roma

Aesthetic cranial reconstruction with 12 grafts Courtesy of Dr. E. Facciuto, Azienda Ospedaliera “A. CARDARELLI”, Napoli Cranio temporal reconstruction Courtesy of Prof. Dr. L. Chiarini / Dr. A. Anesi, Università degli Studi di Modena e Reggio Emilia, Modena

ORTHO/ SPINAL Oncological hip reconstruction with 14 grafts 10 Replacement with vertebral fusion T12/L1 Courtesy of Dr. C. Zoccali, Istituto Regina Elena, Roma Courtesy of Prof. Dr. A. Gasbarrini, Istituto Ortopedico Rizzoli, Bologna Oncological hip reconstruction with 21 grafts Reconstruction of the 3rd cuneiform of the foot Courtesy of Prof. Dr. R. Biagini / Dr. C. Zoccali, Istituto Regina Elena, Roma Courtesy of Prof. Dr. D. A. Campanacci, Azienda ospedaliera universitaria, Firenze

Design studies samples Emimandibular reconstruction Emimandibular reconstruction Bone intramedullary nail for head omerus reconstruction Aesthetic chin surgery

Industrie Biomediche Insubri SA Via Cantonale, 67 Mezzovico-Vira CH-6805 Switzerland Ph. +41 91 93 06 640 www.ibi-sa.com [email protected]