18. Reason for revision surgery after cervical disc arthroplasty based on medical device reports maintained by the United States Food and Drug Administration

BACKGROUND CONTEXT

Cervical disc arthroplasty (CDA) was established in the last two decades as a motion-sparing alternative to anterior cervical discectomy and fusion (ACDF) for degenerative cervical disease, achieving comparable patient-reported and clinical outcomes. Despite showing this outcome difference for various CDA models compared to ACDF, few studies have compared CDA models to one another. One study investigated the range of complications for the different CDAs based on reports from the Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database until 2020, showing variability for each device. However, this study has not reported a detailed look at reported revision cases. To date, literature on complications associated with revision surgery for CDA is limited, mainly comparing CDA to fusion instead of comparing different CDA models to one another.

PURPOSE

To analyze revision cases due to complications related to CDA reported to the MAUDE database.

STUDY DESIGN/SETTING

Retrospective database review.

PATIENT SAMPLE

Nationwide database of reported revision cases related to CDA.

OUTCOME MEASURES

Factors associated with revision for CDA.

METHODS

The MAUDE database was queried for data from January 2005 to September 2023. All the reported complication entries for the nine FDA-approved CDA devices were analyzed. The full-text entries of all complications were analyzed, reported, and grouped depending on the revision surgery performed. For each revision case, the device used, the associated complication, the time until revision, and the type of revision surgery were collected. Those reports with insufficient information or were reported over social media were excluded.

RESULTS

In summary, 1,347 entries were analyzed from the MAUDE database, with the highest number of reports made to the database in 2018 (218). A total of 678 cases reported revision surgery for nine different CDA models: 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 CDA revision were implant migration (23.5%), neck pain (15.5%), and heterotopic ossification (6.6%). The top complication per device was 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 number one cause of revision was evenly split between osteolysis (18.6%) and neck pain (18.6%), while for Simplify, it was neck pain (23.8%). Of the reports that included the type of revision surgery, 283 (54.7%) were recorded as conversion to fusion.

CONCLUSIONS

The MAUDE database highlights complications related to revision cases for CDA, which may not receive sufficient emphasis in existing published studies and can vary depending on the device. Nevertheless, the primary complications linked to CDA revision consistently include implant migration, neck pain, and heterotopic ossification.

FDA Device/Drug Status

This abstract does not discuss or include any applicable devices or drugs.