Dental device-associated problems - 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 devi ce adverse events reported during the study period and uses descriptive sta tistics to depict reporters' occupations, types of adverse events (deaths, injuries, malfunctions), device categories, device problems and patient pro blems. Results. A total of 272,241 device were received during the 35-month study period, 28,555 (10.5 percent) of which involved dental devices. Within thes e reports, two deaths (0.007 percent), 18,406 injuries (64.4 percent) and 9 ,942 device ik malfunctions (34.8 percent) were reported. The most commonly reported dental devices were endosseous implants, which represented more t han 90 percent of all dental percent) device reports. Most reports (84.1 pe rcent provided the reporter's occupation, and the most frequently cited occ upation was dentist (76.3 percent), followed by dental assistant (4.2 perce nt). Conclusions. Dentists and dental staff members are a vital link in the FDA' s adverse event reporting system and are encouraged to report device proble ms to the FDA MedWatch program.