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# 5 Items in ‘Hidden’ FDA Device Database
- URL: https://www.fdaweb.com/5-items-in-hidden-fda-device-database/
- Published: 2019-06-27T12:00:00.000Z
- Updated: 2026-09-15T01:35:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144441

An online Kaiser Health News post lists five key items the service found in its review of a recently published FDA “alternative summary” database often used by medical device manufacturers to report injuries or malfunctions, bypassing the public MAUDE database used by doctors, researchers, and patients. The news service [says](https://www.google.com/amp/s/khn.org/news/six-things-we-found-in-the-fdas-hidden-device-database/amp/?ref=fdaweb.com) the new agency transparency follows Kaiser’s investigation that revealed that for 20 years device manufacturers had been using the alternate database, sending it “millions of reports related to everything from breast implants to surgical staplers.” Kaiser says the five things it gleaned from the database were: 

- blood glucose meters were the subject of 2.4 million reports in 20 years, more unique incidents than any other device in the database;
- there were 2.1 million reports for bad dental implants, including 114,200 last year;
- there were 176 deaths reported through the alternative summary system, even though such reports are not supposed to include deaths;
- malfunctions related to surgical staplers accounted for more than 66,000 previously hidden incidents since 2001; and
- breast implant injuries and malfunctions accounted for nearly 500,000 unique reports over two decades, including implants that leaked, deflated, or migrated.

Kaiser says FDA has replaced the alternative summary with the Voluntary Summary Reporting Program for which more than 87% of device types are eligible for summary reporting of device malfunctions. It says patient advocates say they fear those reports will be as difficult to tally and track as the alternative summaries were.