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

Area of Science:

• Spinal Surgery
• Biomaterials Science
• Medical Device Regulation

Background:

• The Food and Drug Administration (FDA) monitors cervical interbody implants for safety and efficacy.
• Intraoperative malfunctions of these devices can occur and may be overlooked.
• Understanding device failure modes is crucial for patient safety and regulatory oversight.

Purpose of the Study:

• To analyze cervical cage failure rates using a national database of device malfunctions.
• To identify specific manufacturers and design characteristics associated with higher failure rates.
• To assess implant performance relative to market share and manufacturer revenue.

Main Methods:

• A retrospective analysis of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database from 2012 to 2021.
• Categorization of cervical cage malfunctions by failure type, design, and manufacturer.
• Calculation of failure-to-market share and failure-to-revenue indices for comparative analysis.

Main Results:

• Over 1200 cervical cage malfunctions were analyzed, with breakage (28.9%) and instrumentation-related failures (26.2%) being most common.
• Poly-ether-ether-ketone (PEEK) cages showed higher failure rates for migration and breakage compared to titanium.
• Specific manufacturers (Seaspine, Zimmer-Biomet, K2M, LDR) exceeded failure thresholds.

Conclusions:

• Implant breakage is the primary cause of cervical cage malfunction.
• PEEK cages demonstrate a higher propensity for breakage and migration than titanium.
• Failures often occur intraoperatively, emphasizing the need for robust FDA pre-market evaluation under functional loads.