White Paper
Adverse Event Reporting – An FDA Requirement: What, When, Who & How
Presented in 2008
Most orthopaedic surgeons in the course of their practice will encounter and explant medical devices which have failed. Such failures may simply result from long-term in-vivo device usage, component material breakdown, technique at the time of implantation or patient noncompliance. Changes in the Safe Medical Devices Act of 1990 (SMDA), a Law enacted by the…

