Pierce Nunley, Andrew Meyers, Danny Mangual-Perez, Emily Young, Henry Googe, Ian Armstrong, Stacie Tran, Marcus Stone
{"title":"美国市售颈椎间盘置换术设备的骨溶解率：制造商和用户设施设备经验数据库分析。","authors":"Pierce Nunley, Andrew Meyers, Danny Mangual-Perez, Emily Young, Henry Googe, Ian Armstrong, Stacie Tran, Marcus Stone","doi":"10.14444/8772","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Cervical disc arthroplasty (CDA) represents a promising alternative to anterior cervical discectomy and fusion for the treatment of symptomatic degenerative disc disease in appropriately selected patients. It offers the potential benefits of motion preservation and reduced adjacent segment degeneration. However, like any surgical procedure, CDA has associated risks and complications. Among these, postoperative osteolysis, although rare, warrants further investigation to fully understand its incidence, causes, and optimal management strategies. This study's purpose is to elucidate the current incidence of osteolysis following CDA.</p><p><strong>Methods: </strong>The Manufacturer and User Facility Device Experience (MAUDE) database was queried using the \"Brand Name\" function for: \"Mobi C,\" \"Mobi-C,\" \"Prodisc -C,\" \"Prodisc C,\" \"Bryan,\" \"PCM,\" \"Secure-C,\" \"Secure C,\" \"Prestige,\" \"M6,\" and \"Simplify\" from 1 January 2005 to 30 September 2024. Search results were further queried for the word \"osteolysis.\" Osteolysis percentage was calculated as a proportion of a total number of valid reports. The findings from this study were compared with published literature.</p><p><strong>Results: </strong>The total number of osteolysis events reported in the MAUDE database for each disc was 2 Mobi-C, 1 Prodisc-C, 3 Bryan, 0 PCM, 0 Secure-C, 2 Prestige, 138 M6, and 16 Simplify. The highest rate of osteolysis was found in the M6 (36.2%) and Simplify discs (25.8%). Results from the MAUDE database were consistent with previously published literature.</p><p><strong>Conclusion: </strong>While acknowledging the limitations of the MAUDE database, the data presented give rise to substantial concerns regarding the association of osteolysis with the M6 implant. While the reports on the Simplify disc are recent, the current findings indicate a necessity for careful monitoring. Although surgeon participation in the MAUDE database is optional, it is imperative to promptly report any issues with recent technology to ensure fellow surgeons and the public are well informed.</p><p><strong>Clinical relevance: </strong>This report brings to light a clinical concern of osteolysis in cervical TDR surgeries that was not previously discussed. Using these findings, surgeons can look out for signs of osteolysis in earlier follow-up to provide early treatment.</p><p><strong>Level of evidence: 4: </strong></p>","PeriodicalId":38486,"journal":{"name":"International Journal of Spine Surgery","volume":" ","pages":""},"PeriodicalIF":1.7000,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Rates of Osteolysis for Commercially Available Cervical Disc Arthroplasty Devices in the United States: A Manufacturer and User Facility Device Experience Database Analysis.\",\"authors\":\"Pierce Nunley, Andrew Meyers, Danny Mangual-Perez, Emily Young, Henry Googe, Ian Armstrong, Stacie Tran, Marcus Stone\",\"doi\":\"10.14444/8772\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Cervical disc arthroplasty (CDA) represents a promising alternative to anterior cervical discectomy and fusion for the treatment of symptomatic degenerative disc disease in appropriately selected patients. It offers the potential benefits of motion preservation and reduced adjacent segment degeneration. However, like any surgical procedure, CDA has associated risks and complications. Among these, postoperative osteolysis, although rare, warrants further investigation to fully understand its incidence, causes, and optimal management strategies. This study's purpose is to elucidate the current incidence of osteolysis following CDA.</p><p><strong>Methods: </strong>The Manufacturer and User Facility Device Experience (MAUDE) database was queried using the \\\"Brand Name\\\" function for: \\\"Mobi C,\\\" \\\"Mobi-C,\\\" \\\"Prodisc -C,\\\" \\\"Prodisc C,\\\" \\\"Bryan,\\\" \\\"PCM,\\\" \\\"Secure-C,\\\" \\\"Secure C,\\\" \\\"Prestige,\\\" \\\"M6,\\\" and \\\"Simplify\\\" from 1 January 2005 to 30 September 2024. Search results were further queried for the word \\\"osteolysis.\\\" Osteolysis percentage was calculated as a proportion of a total number of valid reports. The findings from this study were compared with published literature.</p><p><strong>Results: </strong>The total number of osteolysis events reported in the MAUDE database for each disc was 2 Mobi-C, 1 Prodisc-C, 3 Bryan, 0 PCM, 0 Secure-C, 2 Prestige, 138 M6, and 16 Simplify. The highest rate of osteolysis was found in the M6 (36.2%) and Simplify discs (25.8%). Results from the MAUDE database were consistent with previously published literature.</p><p><strong>Conclusion: </strong>While acknowledging the limitations of the MAUDE database, the data presented give rise to substantial concerns regarding the association of osteolysis with the M6 implant. While the reports on the Simplify disc are recent, the current findings indicate a necessity for careful monitoring. Although surgeon participation in the MAUDE database is optional, it is imperative to promptly report any issues with recent technology to ensure fellow surgeons and the public are well informed.</p><p><strong>Clinical relevance: </strong>This report brings to light a clinical concern of osteolysis in cervical TDR surgeries that was not previously discussed. Using these findings, surgeons can look out for signs of osteolysis in earlier follow-up to provide early treatment.</p><p><strong>Level of evidence: 4: </strong></p>\",\"PeriodicalId\":38486,\"journal\":{\"name\":\"International Journal of Spine Surgery\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2025-07-18\",\"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/10.14444/8772\",\"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/10.14444/8772","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"SURGERY","Score":null,"Total":0}
Rates of Osteolysis for Commercially Available Cervical Disc Arthroplasty Devices in the United States: A Manufacturer and User Facility Device Experience Database Analysis.
Background: Cervical disc arthroplasty (CDA) represents a promising alternative to anterior cervical discectomy and fusion for the treatment of symptomatic degenerative disc disease in appropriately selected patients. It offers the potential benefits of motion preservation and reduced adjacent segment degeneration. However, like any surgical procedure, CDA has associated risks and complications. Among these, postoperative osteolysis, although rare, warrants further investigation to fully understand its incidence, causes, and optimal management strategies. This study's purpose is to elucidate the current incidence of osteolysis following CDA.
Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried using the "Brand Name" function for: "Mobi C," "Mobi-C," "Prodisc -C," "Prodisc C," "Bryan," "PCM," "Secure-C," "Secure C," "Prestige," "M6," and "Simplify" from 1 January 2005 to 30 September 2024. Search results were further queried for the word "osteolysis." Osteolysis percentage was calculated as a proportion of a total number of valid reports. The findings from this study were compared with published literature.
Results: The total number of osteolysis events reported in the MAUDE database for each disc was 2 Mobi-C, 1 Prodisc-C, 3 Bryan, 0 PCM, 0 Secure-C, 2 Prestige, 138 M6, and 16 Simplify. The highest rate of osteolysis was found in the M6 (36.2%) and Simplify discs (25.8%). Results from the MAUDE database were consistent with previously published literature.
Conclusion: While acknowledging the limitations of the MAUDE database, the data presented give rise to substantial concerns regarding the association of osteolysis with the M6 implant. While the reports on the Simplify disc are recent, the current findings indicate a necessity for careful monitoring. Although surgeon participation in the MAUDE database is optional, it is imperative to promptly report any issues with recent technology to ensure fellow surgeons and the public are well informed.
Clinical relevance: This report brings to light a clinical concern of osteolysis in cervical TDR surgeries that was not previously discussed. Using these findings, surgeons can look out for signs of osteolysis in earlier follow-up to provide early treatment.
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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