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Device problems and user-related events reported for head-mounted augmented reality navigation systems in United States surveillance data

Author

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  • Hernández Martínez, Maria Carla
  • mariacarlahdez1996@gmail.com

Abstract

Introduction: Augmented reality head-mounted displays are entering surgical practice, but their post-market safety profile is undocumented. The objective was to describe the device problems and user-related events reported for these systems in the United States device surveillance database. Methods: Retrospective descriptive study of spontaneous device reports received between 2010 and 2023 and retrieved from the openFDA device event endpoint. Reports were screened for augmented or mixed reality systems with a head-mounted display and analysed by dimension: reporting volume, device component, event type and outcome, user-related events, and relations. Results: Of 490 distinct reports, 44 (9.0%) met the criteria, grouped in 25 events; 41 concerned one spinal navigation system. No report preceded 2020, and none concerned mixed reality headsets, training or wearer symptoms. Injury events accounted for 77.3% of reports (95% CI 63.0-87.2). A user-related cause was stated in 9 events (36.0%) and reference movement in 11. User-related causes were associated with reference movement (odds ratio 8.3; 95% CI 1.4-50.0). Conclusions: Reported problems concerned the registration chain and handling, not the headset display or the wearer. The record is narrow, manufacturer-led and cannot yield event rates.

Suggested Citation

  • Hernández Martínez, Maria Carla & mariacarlahdez1996@gmail.com, 2023. "Device problems and user-related events reported for head-mounted augmented reality navigation systems in United States surveillance data," SAP Gamification and Augmented Reality, South American Publishing.
    • Handle: RePEc:cwf:grarti:gr20232
    DOI: 10.62486/gr20232
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