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Book Chapter
Failure Analysis of Medical Devices
Available to PurchaseSeries: ASM Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.a0006811
EISBN: 978-1-62708-329-4
... holistically, considering patient, device, and surgical factors, when performing a failure analysis of a fractured medical device ( Fig. 2 ). Cardiovascular Implants Long-term cardiovascular implants are intended to treat or prevent a variety of different conditions (including atherosclerosis, heart...
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.
Book
Series: ASM Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.9781627083294
EISBN: 978-1-62708-329-4