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J Am Dent Assoc, Vol 132, No 11, 1540-1548. © 2001 American Dental Association

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An analysis of FDA postmarket surveillance data

Background. The authors provide an analysis of dental device adverse event reports collected through the U.S. Food and Drug Administration’s, or FDA’s, mandatory and voluntary reporting programs between Aug. 1, 1996, and June 30, 1999.

Methods. This study includes an analysis of the total number of dental device adverse events reported during the study period and uses descriptive statistics to depict reporters’ occupations, types of adverse events (deaths, injuries, malfunctions), device categories, device problems and patient problems.

Results. A total of 272,241 device reports were received during the 35-month study period, 28,555 (10.5 percent) of which involved dental devices. Within these reports, two deaths (0.007 percent), 18,406 injuries (64.4 percent) and 9,942 device malfunctions (34.8 percent) were reported. The most commonly reported dental devices were endosseous implants, which represented more than 90 percent of all dental device reports. Most reports (84.1 percent) provided the reporter’s occupation, and the most frequently cited occupation was dentist (76.3 percent), followed by dental assistant (4.2 percent).

Conclusions. Dentists and dental staff members are a vital link in the FDA’s adverse event reporting system and are encouraged to report device problems to the FDA MedWatch program.

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