通常，在头颈部外科中广泛应用的颅颌面重建植入物都被制造为标准样式。在手术过程中，医生必须手工弯折颅颌面重建植入物以匹配不同患者的骨骼解剖结构。弯曲植入物的过程非常耗时，尤其是对于一些缺乏经验的外科医生来说，很难操作。此外，反复的弯折可能会使得植入物内应力集中，在咀嚼载荷作用下易发生疲劳，最终导致植入物疲劳断裂、螺钉松动、骨吸收等并发症。目前已有一些关于3D打印颅颌面重建患者匹配式植入物的报道，但很少有人考虑到植入物的质量问题。在本文中，我们提出了一种制作颅颌面重建3D打印手术植入物的系统性方法。这一方法包括三个部分的内容：首先，我们基于SolidWorks^®软件开发出一个容易使用的设计模块，该模块可帮助外科医生设计手术用颅颌面重建植入物及其辅助工具；设计工程师可以在此基础上进行更详细的设计，并借助有限元模拟来优化设计。接着，制造过程可分为三个步骤进行：第一步检测原材料粉末，第二步设置适当参数进行3D打印，第三步对3D打印产品进行后处理（即热处理和表面处理）以保证植入物的质量和性能。最后，对植入物进行成品检测和消毒后用于颅颌面重建手术中，术后再使用患者信息追踪软件辅助术后康复随访。采用这种方法，目前我们已成功完成了41例手术。3D打印患者匹配式植入物有很多优点，能减少手术时间，加快患者恢复。此外，本文提出的方法也有助于保证植入物的质量安全。

Craniomaxillofacial reconstruction implants, which are extensively used in head and neck surgery, are conventionally made in standardized forms. During surgery, the implant must be bended manually to match the anatomy of the individual bones. The bending process is time-consuming, especially for inexperienced surgeons. Moreover, repetitive bending may induce undesirable internal stress concentration, resulting in fatigue under masticatory loading in vivo and causing various complications such as implant fracture, screw loosening, and bone resorption. There have been reports on the use of patient-specific 3D-printed implants for craniomaxillofacial reconstruction, although few reports have considered implant quality. In this paper, we present a systematic approach for making 3D-printed patient-specific surgical implants for craniomaxillofacial reconstruction. The approach consists of three parts: First, an easy-touse design module is developed using Solidworks^® software, which helps surgeons to design the implants and the axillary fixtures for surgery. Design engineers can then carry out the detailed design and use finite-element simulation (FEM) to optimize the design. Second, the fabrication process is carried out in three steps: ① testing the quality of the powder; ② setting up the appropriate process parameters and running the 3D printing process; and ③ conducting post-processing treatments (i.e., heat and surface treatments) to ensure the quality and performance of the implant. Third, the operation begins after the final checking of the implant and sterilization. After the surgery, postoperative rehabilitation follow-up can be carried out using our patient tracking software. Following this systematic approach, we have successfully conducted a total of 41 surgical cases. 3D-printed patient-specific implants have a number of advantages; in particular, their use reduces surgery time and shortens patient recovery time. Moreover, the presented approach helps to ensure implant quality.