Failure Analysis of Medical Devices

Author:

Bowers Matthew1,Ganot Gabriel1,Malito Louis1,Kondori Babak1,Ezechukwu Anyanwu1,Svedlund Felicia1,James Brad1

Affiliation:

1. Exponent, Inc.

Abstract

Abstract Bearing in mind the three-legged stool approach of device design/manufacturing, patient factors, and surgical technique, this article aims to inform the failure analyst of the metallurgical and materials engineering aspects of a medical device failure investigation. It focuses on the device "failures" that include fracture, wear, and corrosion. The article first discusses failure modes of long-term orthopedic and cardiovascular implants. The article then focuses on short-term implants, typically bone screws and plates. Lastly, failure modes of surgical tools are discussed. The conclusion of this article presents several case studies illustrating the various failure modes discussed throughout.

Publisher

ASM International

Reference92 articles.

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