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Updated: Sep 14, 2025
Longitudinal Micro-Computed Tomography Image Analysis for User-Defined Region of Interest in Critical-Sized Bone Defects
Published on: June 24, 2025
Rates of Osteolysis for Commercially Available Cervical Disc Arthroplasty Devices in the United States: A
Pierce Nunley1, Andrew Meyers2, Danny Mangual-Perez2
1Department of Orthopaedic Surgery, Spine Institute of Louisiana, Shreveport, LA, USA pnunley@louisianaspine.org.
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.
