Reasons for Revision Surgery After Cervical Disk Arthroplasty Based on Medical Device Reports Maintained by the US Food and Drug Administration

作者：Franziska C.S. Altorfer, Michael Kelly, Fedan Avrumova, Jiaqi Zhu, Celeste Abjornson, Darren R. Lebl · 发表于：Spine · 年份：2024 · DOI：10.1097/brs.0000000000005060 · 被引用次数：11 · 研究领域：Cervical and Thoracic Myelopathy、Spine and Intervertebral Disc Pathology、Temporomandibular Joint Disorders

STUDY DESIGN: Retrospective database review. OBJECTIVE: The aim of this study was to analyze revisions of CDAs reported to the MAUDE database. SUMMARY OF BACKGROUND DATA: Cervical disk arthroplasty (CDA) has emerged as a motion-preserving alternative to anterior cervical discectomy and fusion (ACDF) for degenerative cervical disease, demonstrating comparable outcomes. Despite the availability of variable CDA designs, there is limited data on the specific complications of individual CDAs. The Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database has been used to systematically report complications associated with CDAs. However, data on specific reasons for CDA revision remains scarce. The purpose of this study is to compare common complications associated with revision for different CDAs. METHODS: The MAUDE database was queried from January 2005 to September 2023, including all nine FDA-approved CDAs. The full-text reports of each complication were categorized based on whether revision surgery was performed, the complications and the type of CDA collected and compared. RESULTS: A total of 678 revisions for nine CDAs were reported: Mobi-C (239), M6 (167), Prodisc-C (88), Prestige (60), PCM (44), Bryan (35), Secure (23), Simplify (21), and Discover (1). The top three complications associated with revision were migration (23.5%), neck pain (15.5%), and heterotopic ossification (6.6%). The most common complications per device were migration for Mo...