Gregory S Kazarian, Yusef J Jordan, Mitchell Johnson, Satyaj Bhargava, Robert Cecere, Takashi Hirase, Sheeraz Qureshi, James Dowdell, Evan Sheha, Francis Lovecchio, Sravisht Iyer
{"title":"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。","authors":"Gregory S Kazarian, Yusef J Jordan, Mitchell Johnson, Satyaj Bhargava, Robert Cecere, Takashi Hirase, Sheeraz Qureshi, James Dowdell, Evan Sheha, Francis Lovecchio, Sravisht Iyer","doi":"10.14444/8652","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</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). 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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical relevance: </strong>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.</p><p><strong>Level of evidence: 4: </strong></p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":" ","pages":""},"PeriodicalIF":1.7000,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Analysis of 1027 Adverse Events Reports for Interspinous Process Devices From the US Food and Drug Administration Manufacturer and User Facility Device Experience Database.\",\"authors\":\"Gregory S Kazarian, Yusef J Jordan, Mitchell Johnson, Satyaj Bhargava, Robert Cecere, Takashi Hirase, Sheeraz Qureshi, James Dowdell, Evan Sheha, Francis Lovecchio, Sravisht Iyer\",\"doi\":\"10.14444/8652\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</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). 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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical relevance: </strong>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.</p><p><strong>Level of evidence: 4: </strong></p>\",\"PeriodicalId\":38486,\"journal\":{\"name\":\"International Journal of Spine Surgery\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2024-09-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Spine Surgery\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.14444/8652\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"SURGERY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Spine Surgery","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14444/8652","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
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.
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.
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