Electrical shock as the predominant adverse event in reports of intraoral scanners and computer-aided design and manufacturing dental devices

Introduction: Intraoral scanners are central to digital dentistry, but their post-market adverse event profile has not been described from the public reports. Methods: A cross-sectional cohort of adverse event reports for the CAD/CAM optical impression product code was assembled from the openFDA device event database, and the event narratives were classified into failure modes with deterministic keyword rules. Results: Among 36 reports, electrical shock or an electrical sensation was mentioned in 26 (72.2%; 95% CI 56.0 to 84.2), and malfunction and injury were balanced at 41.7% and 38.9%. Component detachment and thermal events each occurred in 5 reports, and fracture in 2. Conclusions: Electrical shock was the predominant adverse event in reports of intraoral scanners, and the reports carried little specific failure-mode information, which points to electrical safety and to reporting quality as the two priorities.