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<p>Dental devices enhance oral health, but carry risks. Adverse events (AEs) can compromise the patient safety and efficacy. This study investigated AEs related to dental devices reported in the Manufacturer and User Facility Device Experience (MAUDE) database. This study examined AEs related to 143 FDA-listed dental devices reported to MAUDE from January 1, 2019, to October 31, 2024. The data were extracted using product codes. The analysis identified patterns of device safety. Over 5.9 years, MAUDE documented 14,274 unique AE reports involving dental devices. Of the 143 FDA-listed devices, 82 reported adverse events. Common device issues included breakage (16.8%), osseointegration failure (16.6%), and fracture (14.7%). Reports included injuries (59%, 8424), malfunctions (40.9%, 5849), and one death. Most reports were from the United States, Switzerland, and Germany. Dentists were the primary reporters, with inputs from healthcare professionals and patients. The most commonly used devices are endosseous dental implants (3000), implant abutments (2939), and dental hand instruments (2021). These findings underscore the critical need to enhance materiovigilance activities concerning dental devices. By identifying devices that pose a high risk and addressing their potential failure modes, stakeholders can significantly improve the safety of the devices and elevate the overall quality of patient care.</p>

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Adverse Events Linked to Dental Devices: An In-depth Analysis of the Manufacturer and User Facility Device Experience Database

  • 期刊论文

  • 发表日期：

    2025年12月7日

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  • Jeesa George,
  • Adusumilli Pramod Kumar,
  • Norah Elsa Shynu,
  • Amish Salil Laxman,
  • Prem Umesh Kale,
  • Vibha Shetty

摘要

Dental devices enhance oral health, but carry risks. Adverse events (AEs) can compromise the patient safety and efficacy. This study investigated AEs related to dental devices reported in the Manufacturer and User Facility Device Experience (MAUDE) database. This study examined AEs related to 143 FDA-listed dental devices reported to MAUDE from January 1, 2019, to October 31, 2024. The data were extracted using product codes. The analysis identified patterns of device safety. Over 5.9 years, MAUDE documented 14,274 unique AE reports involving dental devices. Of the 143 FDA-listed devices, 82 reported adverse events. Common device issues included breakage (16.8%), osseointegration failure (16.6%), and fracture (14.7%). Reports included injuries (59%, 8424), malfunctions (40.9%, 5849), and one death. Most reports were from the United States, Switzerland, and Germany. Dentists were the primary reporters, with inputs from healthcare professionals and patients. The most commonly used devices are endosseous dental implants (3000), implant abutments (2939), and dental hand instruments (2021). These findings underscore the critical need to enhance materiovigilance activities concerning dental devices. By identifying devices that pose a high risk and addressing their potential failure modes, stakeholders can significantly improve the safety of the devices and elevate the overall quality of patient care.