FiberCel Bone Matrix Recall, Warning Issued After Infection Reports
A FiberCel bone matrix recall follows reports of patients who received the grafts developing post-surgical infections, including tuberculosis.
Tag Archives: Bone Graft
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Medtronic Infuse Linked To Neck Problems In Data Kept From FDA For Years
For years, Medtronic sat on more than 1,000 reports of serious complications linked to its Infuse bone growth products, including life-threatening neck conditions.
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Medtronic Faces Investigations Worldwide Over Alleged Improper Conduct, Unsafe Medical Devices: “Implant Files” Report
A new report finds that Medtronic or its subsidiaries were responsible for one-fifth of all medical device recalls last year, and raises questions about the company's commitment to avoid unfair…
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Medtronic Settlement Reached Over Claims Infuse Bone Graft Studies Were Manipulated
A $43 million settlement agreement proposes to resolve an investor lawsuit against Medtronic over manipulating studies linked to its Infuse bone growth product.
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Medtronic Infuse Problems Hidden From Regulators, Report Claims
A new report indicates that Medtronic waited years to inform the FDA of 1,000 adverse event reports linked to complications with the Medtronic Infuse bone growth products.
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Medtronic Infuse Lawsuit Appealed to U.S. Supreme Court Over Off-Label Marketing
The Supreme Court has been asked to weigh in on whether Medtronic is protected by preemption laws if if illegally promoted the Infuse bone growth system for off-label use.
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Side Effects of Bone Graft Substitutes Linked to Child Health Risks, FDA Warns
The FDA is warning doctors to avoid regular use of bone growth products like Medtronics Infuse on children due to the risk of side effects to their still-growing bones.
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Settlements for Medtronic Infuse Bone Growth Lawsuits Cut Into Q4 Profits
Medtronic saw a major drop in profits, in part because of Infuse settlements
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Medtronic Infuse Settlement Agreement Reached For $22M
A $22 million Medtronic Infuse settlement has been reached that resolves 950 claims, but leaves hundreds more unresolved; a number likely to grow as more claims are filed.
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Medtronic Infuse Lawsuits Over Bone Growth Complications Top 1,000
Medtronic says it faces 1,000 lawsuits over its Infuse bone growth product.