College of Medicine, University of Arkansas for Medical Sciences, Little Rock, AR.
Division of Plastic and Reconstructive Surgery, University of California-Los Angeles.
J Craniofac Surg. 2024;35(2):408-411. doi: 10.1097/SCS.0000000000009871. Epub 2023 Nov 16.
Polyether ether ketone (PEEK) custom implants have been fundamental in addressing bone malformations and restoring traumatic defects within the field of craniofacial surgery. Although such implants are generally considered safe and appropriate alternatives to autologous bone grafts, there has been a lack of standardized reporting of adverse events associated with PEEK implants. The purpose of this study is multi-fold: (1) to explore the current landscape of autologous and allogeneic materials utilized for bone grafting; (2) to analyze and characterize adverse events associated within PEEK implants from the widely accredited, FDA-run database, Manufacturer and User Facility Device Experience (MAUDE); and using the data, (3) to provide guidance to craniofacial surgeons using PEEK implants in their surgical practice.
MATERIAL/METHODS: A retrospective review of the adverse events associated with PEEK implants were performed through the FDA-run database, Manufacturer and User Facility Device Experience (MAUDE). The database was surveyed from July 2013 to January 2023. Event types were categorized by injury or malfunction, and device-reported adverse events were recorded, respectively.
Database search initially yielded 77 adverse event reports, but after duplicates were removed, 69 event reports were included in the analysis. These events were sorted into the following categories: device-related and patient-related. Event types were categorized by injury (48.3%) or malfunction (53.6%). The most common reported device-related adverse events were "Poor Fit" (53.6%) and "Adverse Event without Identified Use or Problem " (26.1%). The most common reported patient-related event was "Infection" (32.8%). Of these adverse event reports, 14 (20.2%) patients required a second surgery; 21(30.4%) required implant modification whereas in the operating room; 17 (24.6%) underwent implant removal. Nine (13%) patients experienced operative case delays due to implant modifications.
Infection and poor fit were among the most commonly reported adverse events associated with PEEK customizable implants. Although PEEK implants have been widely implemented in addressing craniofacial bony defects, our database analysis does call for further investigation in studying the long-term outcomes associated with PEEK craniofacial implants. With such analyses and collaboration among plastic surgeons and device engineers, there is great opportunity for innovation of these devices.
聚醚醚酮（PEEK）定制植入物在颅面外科领域中对于骨骼畸形和创伤性缺损的治疗至关重要。尽管此类植入物通常被认为是自体骨移植物的安全且合适的替代物，但对于 PEEK 植入物相关不良事件的报告缺乏标准化。本研究有多个目的：（1）探索用于骨移植的自体和同种异体材料的现状；（2）分析和描述广泛认可的 FDA 运行的制造商和用户设施设备经验（MAUDE）数据库中与 PEEK 植入物相关的不良事件；并利用这些数据，（3）为在手术实践中使用 PEEK 植入物的颅面外科医生提供指导。
材料/方法：通过 FDA 运行的制造商和用户设施设备经验（MAUDE）数据库对 PEEK 植入物相关的不良事件进行回顾性研究。该数据库的调查时间从 2013 年 7 月到 2023 年 1 月。根据损伤或故障的类型对事件类型进行分类，并分别记录设备报告的不良事件。
数据库搜索最初产生了 77 份不良事件报告，但在去除重复项后，有 69 份事件报告被纳入分析。这些事件被分为设备相关和患者相关两类。根据损伤（48.3%）或故障（53.6%）对事件类型进行分类。最常见的设备相关不良事件报告为“不合适”（53.6%）和“无识别使用或问题的不良事件”（26.1%）。最常见的患者相关不良事件为“感染”（32.8%）。在这些不良事件报告中，有 14 名（20.2%）患者需要进行第二次手术；21 名（30.4%）患者需要在手术室中对植入物进行修改；17 名（24.6%）患者需要取出植入物。由于植入物修改，9 名（13%）患者的手术出现延误。
感染和不合适是与 PEEK 可定制植入物相关的最常见不良事件。尽管 PEEK 植入物已广泛应用于治疗颅面骨缺损，但我们的数据库分析确实需要进一步研究与 PEEK 颅面植入物相关的长期结果。通过这些分析以及整形外科医生和设备工程师之间的合作，为这些设备的创新提供了很好的机会。
