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. 2024 Apr 15;49(8):553-560.
doi: 10.1097/BRS.0000000000004638. Epub 2023 Mar 27.

Are all Cages Created Equal? Analysis of Cervical Cage Malfunctions Using FDA MAUDE Database

Victor Ungurean Jr  1 , Amit S Piple  1 , Oluwatodimu Richard Raji  1   2 , Andrea Rowland  2 , Adam Schlauch  2 , Dimitriy G Kondrashov  2   3 , Ken Y Hsu  2   3 , James F Zucherman  1   2   3
Affiliations

Are all Cages Created Equal? Analysis of Cervical Cage Malfunctions Using FDA MAUDE Database

Victor Ungurean Jr et al. Spine (Phila Pa 1976). .

Abstract

Study design: Retrospective case series.

Objective: To characterize failure rates of cervical cages based on manufacturer and design characteristics using the nationwide database of reported malfunctions.

Background: The Food and Drug Administration (FDA) aims to ensure the safety and efficacy of cervical interbody implants postimplantation; however, intraoperative malfunctions may be overlooked.

Materials and methods: The FDA's Manufacturer and User Facility Device Experience database was queried for reports of cervical cage device malfunctions from 2012 to 2021. Each report was categorized based on the failure type, implant design, and manufacturer. Two market analyses were performed. First, "failure-to-market share indices" were generated by dividing the number of failures per year for each implant material by its yearly US market share in cervical spine fusion. Second, "failure-to-revenue indices" were calculated by dividing the total number of failures per year for each manufacturer by their approximate yearly revenue from spinal implants in the US. Outlier analysis was performed to generate a threshold value above which failure rates were defined as greater than the normal index.

Results: In total, 1336 entries were identified, and 1225 met the inclusion criteria. Of these, 354 (28.9%) were cage breakages, 54 (4.4%) were cage migrations, 321 (26.2%) were instrumentation-related failures, 301 (24.6%) were assembly failures, and 195 (15.9%) were screw failures. Poly-ether-ether-ketone implants had higher failure by market share indices for both migration and breakage compared with titanium. Upon manufacturer market analysis, Seaspine, Zimmer-Biomet, K2M, and LDR exceeded the failure threshold.

Conclusion: The most common cause of implant malfunction was breakage. Poly-ether-ether-ketone cages were more likely to break and migrate compared with titanium ones. Many of these implant failures occurred intraoperatively during instrumentation, which underscores the need for FDA evaluation of these implants and their accompanying instrumentation under the appropriate loading conditions before commercial approval.

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Conflict of interest statement

O.R.R.: Paid consultant for Aurora Spine and Pain Care, PainTEQ, Osteo Centric Technologies, Facet Dynamics, and Olympus Terumo Biomaterials. D.G.K.: Research Support for AO Foundation; Paid consultant and Paid presenter or speaker for SI, Bone, Spineart; IP Royalties: Spineart. K.Y.H.: Stock or stock options: Sparktek Medical Technology. J.F.Z.: Paid consultant: Ivivi, Benvenue, Nocimed; Unpaid consultant: Spine 21; Stock options: Nocimed, Spine 21; Stock or stock options: Benvenue, Ivivi, Rio Grande, Spartek, and Active Implants. The remaining authors report no conflicts of interest.

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