Ten-Year Risk of Recall of Novel Spine Devices.

Autor:	Ansley B; Department of Orthopedic Surgery, University of Missouri-Kansas City, MO., Koreckij T; Kansas City Orthopedic Alliance., Jin A; University of Missouri-Kansas City School of Medicine, Kansas City, MO., Bouloussa H; Department of Orthopedic Surgery, University of Missouri-Kansas City, MO., Cheng AL; Department of Medical Health and Informatics, University of Missouri-Kansas City, MO., Dubin J; Department of Orthopedic Surgery, University of Missouri-Kansas City, MO.
Jazyk:	angličtina
Zdroj:	Spine [Spine (Phila Pa 1976)] 2024 Nov 01; Vol. 49 (21), pp. E361-E366. Date of Electronic Publication: 2024 Jan 26.
DOI:	10.1097/BRS.0000000000004939
Abstrakt:	Study Design: Observational epidemiological study. Objective: This study's primary objective was to examine the risk of recall for novel spine devices over time. Secondarily, we sought to analyze interbody fusion and vertebral body replacement (VBR) devices (corpectomy cages) as a risk factor for recall. Background: The recall risk of a novel spine device over time has not been reported. In addition, FDA regulations were lowered for interbody fusion devices to enter the market in 2007. As well, VBR implants were recently approved by the FDA for use in the cervical spine in 2015. Materials and Methods: Spine devices cleared between January 1, 2008 and December 31, 2018 were identified from the FDA's 510(k) database. All recall data were collected from the database in January 2021 to provide a 2-year minimum follow-up for a recall to occur. Product labels were used to classify interbody fusion and VBR devices. Cumulative incidence function was conducted to compare the overall risk of recall for FDA-cleared spine devices, and the hazard ratio determined for VBR and all other devices versus interbody implants during the study period. Results: A total of 2384 spine devices were cleared through 510(k) in the study period. The hazard of recall at 5 years was 5.3% (95% CI: 4.4%-6.2%) and 6.5% (95% CI: 5.4%-7.7%) at 10 years. No significant difference in recall risk was identified for interbody fusion and VBR devices. Conclusion: The risk of recall at 5 and 10 years of a novel spine device is about half the 12% rate reported for orthopedic devices in general. Despite lowered FDA regulations for interbody fusion devices and recent approval for VBR device use in the cervical spine, no increased risk of recall was detected. Further research is necessary to explain the reason for the lower risk of recall with spine devices. Level of Evidence: 4. Competing Interests: The authors report no conflicts of interest. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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