Ten-year analysis of 17,639 thoracolumbar instrumentation failures using the manufacturer and user facility device experience (MAUDE) database
Failure profiles for pedicle screw systems vary significantly between manufacturers. The MAUDE database is a useful resource for the evaluation of reporting patterns associated with pedicle screw systems. However, limitations include reporting biases and the absence of total sales data, which prevents the calculation of true failure rates.
Authors
- Darcy Lynn. Johnston
- Gil Kimchi (ORCID: https://orcid.org/0000-0003-1273-9534)
- Jill A Serbousek
- John Paul G. Kolcun
- Richard G Fessler
Institutions
- Rush University Medical Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- Clinical Innovations (United States) (US)
- Independent Age (GB)
Publication Details
- Journal
- North American Spine Society Journal (NASSJ)
- Published
- 2026-02-05
- DOI
- https://doi.org/10.1016/j.xnsj.2026.100861
- Primary Topic
- Automotive and Human Injury Biomechanics
- Type
- article
- Field-Weighted Citation Impact
- 0.00