A cross-sectional analysis of 284 complications for lumbar disc replacements from medical device reports maintained by the United States Food and Drug Administration

Abstract

Background context: Lumbar disc replacement (LDR) is a motion sparing procedure for degenerative disc disease. When compared to lumbar fusion, this procedure may reduce complications, reoperations, operative time, and length of stay. However, the extent of overall complications related to LDR has not been well defined in the literature.

Purpose: Demonstrate the complication profile of popular LDR implants reported to the Food and Drug Administration (FDA).

Study design: Retrospective database review.

Patient sample: Nationwide database of reported complications related to LDR products from patients throughout the country.

Outcome measures: Complications related to LDR.

Methods: Data files from January 1, 2004 to April 1, 2021 were queried using the publicly accessible Manufacturer and User Facility Device Experience (MAUDE) database and Alternative Summary Reporting program. Three LDR ("Charité," "Prodisc-L," and "Activ L") products were analyzed for complications. Data collected included the date the reports were received by the FDA, the type of complication, complication event description, and the source of the report. The complication event description was utilized to determine the completion of the investigation. Entries with insufficient information were excluded. Complications were further divided into two categories, device and non-device related.

Results: A total of 431 complication entries were found between January 1, 2004, and April 1, 2021. After screening for duplicates and events with insufficient information there were 284 total complications. The total complications were then further divided into implant and non-implant related. The five most common overall complications were lumbar pain (49 entries, 17.25%), migration of implant (42 entries, 14.78%), polyethylene dislodged (37 entries, 13.0%), insertion of device problem (37 entries, 13.0%), device handling problem (12 entries, 4.22%). The most common implant related complication, along with the number of MAUDE entries for each implant was migration of implant for Charité (n=6); Migration of implant for ActivL (n=24); Polyethylene dislodged for ProdiscL (n=32). Of the 284 total complications analyzed, 86 (30.28%) of the entries were deemed "investigation completed." The majority of reports were submitted from the manufacturer and company representative (66.2%, 14.8 % respectively). There were no entries related to LDR within the Alternative Summary Reporting search.

Conclusions: This study outlined the complications of LDR implants from the MAUDE database which have not always been highlighted in previously published studies. The findings of this study provide insight into the potential targets for improvement in future LDR design and surgical techniques to reduce complications and ensure the safe utilization of these implants.

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