Anesth Pain Med.  2021 Apr;16(2):177-183. 10.17085/apm.20093.

Real world adverse events of interspinous spacers using Manufacturer and User Facility Device Experience data

• Aggarwal N
• Chow R

• KMID: 2515544
• DOI: http://doi.org/10.17085/apm.20093

Abstract

Background
Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile.
Methods
A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration.
Results
Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms.
Conclusions
Further studies such as randomized controlled trials are needed to validate the findings.

Keyword

Clinical significance; Coflex; Compression fracture; Disproportionality analysis; Interspinous spacer; Interventional; MAUDE database; Veriflex; X-Stop

Figure

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  Fig. 1. Graphical depiction of data acquisition and processing.

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  Fig. 2. Formulas for calculating PRR and ROR.

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  Fig. 3. Heat Map for each of the spinous process spacers/plates and adverse event combinations. IC025 for each device by adverse event is displayed in the center of the box. Color is coded by IC025 with values greater than 0 being green and those less than 0 being yellow/red. The size of each box is representative of the relative number of adverse events for that device and adverse event combination. CSF: cerebrospinal fluid, IC: information component. *These device and adverse event combinations had 0 reports and are shown with the smallest box size.

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