1542. Device Learnings: A Comparison of Adverse Events Between Cervical Disc Arthroplasties and Anterior Cervical Discectomy and Fusion

Authors: Destie Provenzano; Nilesh Vyas, MD (Arlington, VA)

Introduction: Cervical disc arthroplasties (Cervical Disc Protheses) are a total disc replacement alternative to anterior cervical discectomy and fusion (ACDF). Characterizing device failures is important to distinguish if the slow rise in popularity of cervical disc replacement systems is due to a learning curve, product malfunctions, or other factor. This study serves to summarize adverse events (AEs) reported by the FDA and examine potential causes of this adoption discrepancy. Methods: The OpenFDA program (http://openfda.shinyapps.io/devicereports/) was queried using the R API for the product codes MJO (Cervical Disc Prothesis) and KWQ (Anterior Cervical Plate - ACDF) between 1993 and April of 2018. For each device: total AEs, date reported, severity, FDA product approval date, and text analytics were reported. Data was compared to known total procedure dates according to the National Inpatient Survey, vendor information, and FDA reported device approval dates. Results: A total of 3,093 AEs for “MJO” (Cervical Disc Prothesis) and 7,056 AEs for “KWQ” (ACDF) were recorded. Both groups increased over time, however had separate “spikes” in different years (ACDF: 2000, 2005, 2010, 2013; Disc Arthroplasty: 2005, 2007, 2009, 2013, 2015). Disc arthroplasty “spikes” followed new device approval dates (1.22% overall), whereas ACDF maintained a trend over time (0.10% overall). ACDF had a higher proportion of product malfunctions at 38% (57% resulting in injury) compared to 14% of disc arthroplasties (85% associated with injury). Conclusion: This study is the first to characterize FDA reported adverse events for cervical disc arthroplasties compared to ACDF. Cervical disc arthroplasty spikes and lower rate of product malfunctions suggest a standard new product learning curve, and that AEs may continue to decrease. This study is limited due to reliance on self-reported FDA data. Further prospective studies may provide better insight into the safety and trends of adoption.