Ten-Year Risk of Recall of Novel Spine Devices.

Abstract

Observational epidemiological study. 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. 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 b