对美国食品药品管理局制造商和用户机构设备经验数据库中有关椎间孔镜设备的 1027 份不良事件报告的分析。

IF 1.7 Q2 SURGERY International Journal of Spine Surgery Pub Date : 2024-09-26 DOI:10.14444/8652
Gregory S Kazarian, Yusef J Jordan, Mitchell Johnson, Satyaj Bhargava, Robert Cecere, Takashi Hirase, Sheeraz Qureshi, James Dowdell, Evan Sheha, Francis Lovecchio, Sravisht Iyer
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The purpose of this study was to describe the adverse events associated with IPDs.</p><p><strong>Study design: </strong>This was a retrospective review of the Food and Drug Administration Manufacturer and User Facility Device Experience database.</p><p><strong>Methods: </strong>The database was queried from its inception to November 2022 for reports associated with \"Prosthesis, Spinous Process Spacer/Plate.\" Entries were categorized by event type, patient impact, and interventions.</p><p><strong>Results: </strong>A total of 943 surgery-related adverse events were identified. The most common intraoperative events were implant malfunctions (39.7%, <i>n</i> = 374) and fractures (2.2%, <i>n</i> = 21). The most common postoperative events were persistent pain (26.6%, <i>n</i> = 251), implant migration (19.1%, <i>n</i> = 180), and fracture (6.8%, <i>n</i> = 64). The most common resultant outcome of an adverse event was the need for revision surgery (48.8%, <i>n</i> = 460). 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引用次数: 0

摘要

背景:棘突间装置(IPD)为无融合手术减压带来了一类新的并发症:硬件相关并发症。本研究旨在描述与 IPD 相关的不良事件:研究设计:这是对食品药品管理局制造商和用户机构设备经验数据库的回顾性审查:从数据库建立之初到 2022 年 11 月,对与 "假体、棘突垫片/板 "相关的报告进行了查询。条目按事件类型、对患者的影响和干预措施进行分类:结果:共发现 943 例手术相关不良事件。最常见的术中事件是植入物故障(39.7%,n = 374)和骨折(2.2%,n = 21)。最常见的术后事件是持续疼痛(26.6%,n = 251)、植入物移位(19.1%,n = 180)和骨折(6.8%,n = 64)。最常见的不良事件结果是需要进行翻修手术(48.8%,n = 460)。骨折(47.1%)、植入物移位(84.5%)、感染(76.7%)和神经系统并发症(76.9%)是需要进行翻修手术的常见原因。与传统的椎板切除术相比,植入体移位、骨折和植入体故障是IPD减压术特有的3种并发症,这3种并发症占到翻修手术的45.9%(211/460),在报告了其中1种并发症的病例中,33.0%需要进行翻修(211/640)。在Coflex并发症中,21.2%的病例出现植入物故障;在Superion并发症中,47.3%的病例出现植入物故障;在X-Stop并发症中,5.2%的病例出现植入物故障:结论:最常见的不良事件是植入物故障、疗效不佳、植入物移位和骨折。令人担忧的是,在出现这些并发症时,有三分之一的病例需要进行翻修手术。针对植入物的评估显示,Coflex 和 Superion 植入物的植入物故障率较高:棘突间装置为孤立脊柱减压手术带来了一类新的并发症:植入物相关并发症。这些并发症在术中和术后都会发生,而且经常需要进行翻修手术:4:
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Analysis of 1027 Adverse Events Reports for Interspinous Process Devices From the US Food and Drug Administration Manufacturer and User Facility Device Experience Database.

Background: Interspinous process devices (IPDs) introduce a new class of complications to surgical decompression without fusion: hardware-related complications. The purpose of this study was to describe the adverse events associated with IPDs.

Study design: This was a retrospective review of the Food and Drug Administration Manufacturer and User Facility Device Experience database.

Methods: The database was queried from its inception to November 2022 for reports associated with "Prosthesis, Spinous Process Spacer/Plate." Entries were categorized by event type, patient impact, and interventions.

Results: A total of 943 surgery-related adverse events were identified. The most common intraoperative events were implant malfunctions (39.7%, n = 374) and fractures (2.2%, n = 21). The most common postoperative events were persistent pain (26.6%, n = 251), implant migration (19.1%, n = 180), and fracture (6.8%, n = 64). The most common resultant outcome of an adverse event was the need for revision surgery (48.8%, n = 460). The need for revision surgery was common in patients who experienced fracture (47.1%), implant migration (84.5%), infection (76.7%), and neurological complications (76.9%). Implant migration, fracture, and implant malfunction, 3 complications that are unique to decompression with an IPD as compared with traditional laminectomy, accounted for 45.9% of revisions (211/460), and revision was required in 33.0% of cases where 1 of these complications was reported (211/640). Implant malfunction made up 21.2% of Coflex complications, 47.3% of Superion complications, and 5.2% of X-Stop complications.

Conclusions: The most common adverse events were implant malfunction, inadequate efficacy, implant migration, and fracture. Concerningly, these complications require revision surgery in one-third of cases when they occur. Implant-specific assessments demonstrate a high prevalence of implant malfunctions for the Coflex and Superion implants.

Clinical relevance: Interspinous process devices introduce a new class of complications to isolated spinal decompression surgery: implant-related complications. These complications occur both intraoperatively and postoperatively, and they frequently necessitate revision surgery.

Level of evidence: 4:

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来源期刊
CiteScore
3.10
自引率
0.00%
发文量
162
期刊介绍: The International Journal of Spine Surgery is the official scientific journal of ISASS, the International Intradiscal Therapy Society, the Pittsburgh Spine Summit, and the Büttner-Janz Spinefoundation, and is an official partner of the Southern Neurosurgical Society. The goal of the International Journal of Spine Surgery is to promote and disseminate online the most up-to-date scientific and clinical research into innovations in motion preservation and new spinal surgery technology, including basic science, biologics, and tissue engineering. The Journal is dedicated to educating spine surgeons worldwide by reporting on the scientific basis, indications, surgical techniques, complications, outcomes, and follow-up data for promising spinal procedures.
期刊最新文献
Beyond the Limits to Become a Leading Force in Global Spine Surgery: Present and Future of Spine Surgery in Asia-Pacific. Comparing ACDF Outcomes by Cervical Spine Level: A Single Center Retrospective Cohort Study. Editorial: Embracing Rasch Analysis for Enhanced Spine Surgery Outcomes-The Outsider's Viewpoint. Editors' Introduction: High-Value Endoscopic Techniques: Integrating Surgeon Skill and Experience in Spine Surgery With Rasch Analysis. Invited Commentary: Rasch Analysis and High-Value Spinal Endoscopy.
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