Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Medtronic patient sues over off-label Infuse injury

This article was originally published in Clinica

Executive Summary

Medtronic is being sued by one of its patients who claims to have been seriously injured by the unapproved use of the firm’s Infuse bone graft implant. Representatives of Paul Antonelli say the plaintiff was injured in January 2006 during an off-label surgical procedure to fuse vertebrae in his spine, leaving him in agonising pain. The complaint alleges that Medtronic improperly promoted the use of the bone graft for cervical lumbar surgery, when the technology had not been approved by the FDA for that particular procedure. The FDA has received more than 200 reports of significant side effects resulting from off-label use of Infuse, particularly in the cervical spine. In December, the firm was sued by representatives of a former Infuse patient who claim she that died after suffocating from severe throat and neck swelling caused by the device (see Clinica No 1329, p 17).

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT041670

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel