Sample Case Report Orthognathic Demo 2 Surgeon Name Orthognathic surgery

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Roberta Harrell
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1 Sample Case Report Orthognathic Demo 2 Surgeon Name Orthognathic surgery DSUS/CMF/0514/0100

Case Summary Patient Name: N/A Surgeon Name: N/A Hospital: N/A Surgery Date: N/A 2 of 17 Summary - Lefort 1 Maxillary Surgery - Bi-sagittal split mandibular sugery - Genioplasty SD900.

106: Patient Specific Splint, Orthognathic, Final - Teeth impression: Up to Brackets - Buccal contour: thin Disclaimer: A soft tissue simulation displays a prediction of the behavior of the patient s

2 Case Summary Patient Name: N/A Surgeon Name: N/A Hospital: N/A Surgery Date: N/A 2 of 17 Summary - Lefort 1 Maxillary Surgery - Bi-sagittal split mandibular sugery - Genioplasty SD : Patient Specific Splint, Orthognathic, Intermediate - Teeth impression: Up to Brackets - Buccal contour: thin SD : Patient Specific Splint, Orthognathic, Final - Teeth impression: Up to Brackets - Buccal contour: thin Disclaimer: A soft tissue simulation displays a prediction of the behavior of the patient s soft tissue after surgically modifying the facial skeleton. Although the biomechanical algorithm has been successfully validated on real-life cases, no guarantees are given on the accuracy of the predicted outcome on specific patients or surgical routines. Interpret the results with clinical judgment. Contact us: Materialise CMF US: DePuy Synthes CMF Customization: Clinical Engineer: N/A

3 Delivered Patient Specific Medical Instrumen nts Kit reference Item reference Unique instrument ID Description SD SD DEMO2-01 Patient Specific Splint, Orthognathic, Intermediate 3 of 17 Preview SD SD DEMO2-02 Patient Specific Splint, Orthognathic, Final Contact us: Materialise CMF US: DePuy Synthes CMF Customization:

4 Surgical Plan: Pre-Operative situation Condyles/Mandibular position set according to preoperative dental model occlusion. 4 of 17

5 Surgical Plan: Lefort 1 and BSSO osteotomy 5 of 17

6 Surgical Plan: Intermediatee position n (Maxilla movement first) 6 of 17 Maxilla impacted 4mm, advanced 3mm, cant corrected about midline (only 1mm difference between left and right cuspid)

7 Surgical Plan: Final position Mandible moved into final occlusion with maxilla. 7 of 17

8 Surgical Plan: Genioplasty Genioplasty bodily translated left 1.5mm and advanced 6mm 8 of 17

9 Surgical Plan: Maxilla movement 9 of 17 Preoperative Cant is 2mm between cuspids Measurements at Lefort Osteotomy Planned Cant Correction leaves only 1mmm between cupsids (rotation done about midline) No yaw corrected done in planning (red lines indicated symmetry of cuspids and 1 st molars)

10 Surgical Plan: Proximal segment analysis and Genioplasty 10 of 17

11 Surgical Plan: Movements analysiss 11 of 17 Please note: The mandible measurements shown below are referenced from its original position, at the time the CT was taken. Point A ANS Me Pog Maxilla Medial L Maxilla 1st Molar L Maxilla Lateral R Maxilla Medial R Mandible 1st Molar R Mandible Incisor Midline Mandible Canine L Maxilla 1st Molar R Mandible Canine R Maxilla Lateral L Maxilla Canine L Mandible 1st Molar L Maxilla Incisor Midline Maxilla Canine R Left/Rightt (mm) 0.5 Left 0.6 Left 0.8 Right 0.6 Right 0.6 Left 0.1 Left 0.6 Left 0.6 Left 0.1 Left Left 0.1 Left 0.1 Left 0.6 Left Left Ant/Post (mm) 13.3 Anterior 13.1 Anterior 6.3 Anterior 6.3 Anterior 6.3 Anterior 6.3 Anterior 6.3 Anterior Up/Down (mm) 4.0 Up 4.0 Up 5.8 Up 5.9 Up 3.7 Up 3.5 Up 4.7 Up 4.3 Up 5.3 Up 5.3 Up 4.9 Up 4.5 Up 5.4 Up 3.4 Up 3.6 Up 4.5 Up 4.0 Up 4.4 Up

12 Surgical Plan Basic Lateral Cephalometry Preoperative: SNA = 84.1 ; SNB = 74.5 ; ANB = 9.6 ; Postoperative: SNA = 87.7 ; SNB = 78.3 ; ANB = 9.4 ; 12 of 17 Preoperative Simulated Postoperative

13 Surgical Plan Occlusal Plane Measured from the Frankfurt Horizontal 13 of 17 Preoperative Occlusal Angle = 13 Simulated Postoperative Occlusal Angle = 13

14 Surgical Plan: Final positio on with simulated soft tissue 14 of 17 Note: A soft tissue simulation displays a prediction of the behavior of the patient s soft tissue after surgically modifying the facial skeleton. Although the biomechanical algorithm has been successfully validated on real life cases, no guarantees are given on the accuracy of the predicted outcome on specific patients or surgical routines. Interpret the results with clinical judgment.

15 Guide design: Intermediatee splint (M Maxilla surgery first) 15 of 17 Intermediate splint: teethh impression = up to brackets, buccal contours = thin Maxilla teethh Mandible teeth Intermediatee splint

16 Guide design: Final splint 16 of 17 Final splint: teeth impression = up to brackets, buccal contours = thin Maxilla teethh Mandible teeth Final splint

17 Limitation of liability 17 of 17 Though all necessary precautions were taken to ensure that the devices are accurate and fulfill all internal quality requirements, Materialise N.V. does not take any medical responsibility. The delivered devices should always be examined before use. Before using the devices during surgery, they should be sterilized according to the instuctions indicated in the enclosed Instructions for Use. Materialise N.V. is liable as a supplier of products. Since the circumstances in whichh these products are ordered and used are under control of the buyer, the latter recognizes his responsibility for these circumstances. On these grounds the remediess of the buyer are limited as follows: The liability of Materialise N.V. for real and proven damages will, regardless of the gravity of the failure, except in case of fraud, be limited to the price of the product directly related to the reason of the claim. Under no circumstances an indemnity can be grounded on indirect damages such as, but not limited to, loss of revenue, increase of expenses, disturbance of planning, loss of customers or goodwill, loss of benefits or expected savings or any other financial or commercial losses which are not a direct and immediate consequence of a shortcoming of Materialise N.V. in its obligations. Buyer agrees to control the conformity of any delivered product with his order, beforee using it. Shouldd buyer omit to perform such control or decide to nevertheless use a non conformable product, he frees Materialisee N.V. from any liability for the consequences of the use of such product. Privacy statement t Materialise values the importance of protection of private data. Any personal information (in particular, medical information of a private individual), which is received by Materialise in the course of her operations, will be used only in connection withh the purpose for which it has been submitted. Any such information will not be sent to any third party. Materialise s internal privacy policy provides measures to ensure an appropriate protection of any personal information, for example by limiting the access to this information. Upon simple request from the individual concerned, Materialise grants access to the personal information, and will apply any corrections requested.

Synthes ProPlan CMF. Case Report MUXX-XXX-XXX Orthognathic. F MPROD DJ7253 A For Training Purposes Only Do Not Distribute

Synthes ProPlan CMF. Case Report MUXX-XXX-XXX Orthognathic. F MPROD DJ7253 A For Training Purposes Only Do Not Distribute Synthes ProPlan CMF Case Report MUXX-XXX-XXX Orthognathic 2 of 13 Case Summary Orthognathic Surgery Lefort I and BSSO Maxillary and Mandibular rotation of 6 clockwise and 2 mm advancement Intermediate