A cross-sectional analysis of 1347 complications for cervical disc replacements from medical device reports maintained by the United States Food and Drug Administration


Background context: Cervical disc replacement (CDR) has increased in popularity over the past decade based on published outcomes from FDA IDE studies with narrowly defined inclusion and exclusion criteria. A low rate of complications was noted in these studies. The broader complication profile for CDR in widespread clinical practice has yet to be described.

Purpose: To outline the complications reported to the FDA regarding commonly used CDR products STUDY DESIGN/SETTING: Retrospective database review PATIENT SAMPLE: Nationwide database of reported complications related to CDR products from patients across the country OUTCOME MEASURES: Complications related to CDR METHODS: We queried the MAUDE database and Alternative Summary Reporting (ASR) data files submitted between January 2005 to March 2020. The complications listed for seven FDA-approved CDR implants were analyzed. The entries in the databases were cataloged for complication type, date of entry, source of report, and whether the investigation was “complete”. Reports that had too little information to extract relevant data were excluded.

Results: There were 1,517 entries identified in the MAUDE database. After removal of duplicate entries and entries without sufficient information, there were 1,347 entries analyzed. The top five complications were (1) migration of implant (338 entries, 25.2%) (2) insertion problem/failure (312 entries, 23.3%) (3) neck pain (203 entries, 15.2%) (4) heterotopic ossification (108 entries, 8.1%) and (5) radiculopathy (90 entries, 8.1%). The number of analyzed implant-related MAUDE entries and most common implant-related complication for each implant was 209 entries for insertion problem/failure for Mobi-C; 158 entries for migration of implant for ProDisc-C; 154 entries for insertion problem/failure for Bryan cervical disc; 130 entries for migration of implant for Prestige cervical disc; 49 entries for migration of implant for PCM cervical disc; 12 entries for migration of implant for M6 and 10 entries for migration of implant for Secure-C. Only 263 entries (19.5%) were deemed “complete”. Most entries were from the manufacturer/company representative/distributor (923 entries, 70%). There were no entries related to cervical disc replacement devices within the ASR data.

Conclusions: The MAUDE database highlights complications related to CDR implants that may not be emphasized in currently published studies. It is important to understand this broad complication profile for CDR to ensure safe utilization of this new technology.

Keywords: Cervical disc arthroplasty; Cervical disc replacement; Complication database; Device complications; Device monitoring; FDA; IDE trials; MAUDE.

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