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

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 Mobi-C (26.4%), Prodisc-C (21.3%), Prestige (24.6%), PCM (84.1%), Bryan (48.6%), Secure (30.4%), and Discover (100%). For M6, the most common complications associated with revision surgery were osteolysis (18.6%) and neck pain (18.6%), while neck pain (23.8%) was the most common for the Simplify.
Conclusions: The MAUDE database highlights complications related to CDA revision in which the primary complications consistently include implant migration, neck pain, and heterotopic ossification, varying in their rerelvance depending on the CDA.
Level of Evidence: Level II.
Competing Interests: C.A. is a consultant on the advisory board for Camber Spine Tech; a consultant for Centinel Spine Inc.; is in the advisory board, and has an ownership interest in Orthobond Corporation and Surgalign. D.R.L. is a consultant and on the advisory board for Choice Spine; is a consultant for Depuy Synthes; has ownership interest from Woven Orthopedic Technologies, Vestia Ventures MiRus Investment LLC, HS2 LLC, and ISPH II LLC; has research support from Medtronic Sofamor Danek USA Inc.; has royalties from Nuvasive Inc.; is on the advisory board and has ownership interest from Remedy Logic; is a consultant and has royalties from Stryker; is a consultant and has ownership interest from Viseon Inc. The remaining authors report no conflicts of interest.
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