Table of contents
- Latest Medtronic CD Horizon Spinal System Lawsuit Updates
- May 7, 2021: FDA Terminates CD Horizon Screw Recall
- August 14, 2019: Arizona Court Rules in Jones Case
- July 9, 2018: Medtronic Starts Screw Removal
- August 10, 2010: FDA Terminates Agile Device Recall
- September 11, 2008: FDA Posts Agile Device Recall
- November 12, 2007: Medtronic Begins Agile Recall
- What Is the CD Horizon Spinal System?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- What Are the Side Effects of the Medtronic CD Horizon Spinal System?
- Has the CD Horizon Spinal System Been Recalled?
- What Does the Research Say About CD Horizon Complications?
- Who Is the Plaintiff in the Jones Case?
The Medtronic CD Horizon Spinal System has two FDA Class 2 recalls, both terminated. One was for cable shear failure in the Agile device and one for a mislabeled screw size.
No MDL or class action covers the system. Jones v. Medtronic, an individual federal case in Arizona, is the only lawsuit naming a CD Horizon implant. It involves Infuse Bone Graft and PEEK devices, with a CD Horizon implant alongside.
Claims in the court case are allegations, not findings. The recalled parts are the Agile dynamic stabilization device and one lot of multiaxial screws for 5.5/6.0 mm rods.
Latest Medtronic CD Horizon Spinal System Lawsuit Updates
May 7, 2021: FDA Terminates CD Horizon Screw Recall
On May 7, 2021, the FDA terminated Class 2 recall Z-2603-2018 of the CD Horizon multiaxial screw for 5.5/6.0 mm rods. The recall covered lot 0648247W, and the record lists US distribution only.
August 14, 2019: Arizona Court Rules in Jones Case
On August 14, 2019, the U.S. District Court for the District of Arizona signed an order on the defendants’ motion to dismiss the amended complaint in Jones v. Medtronic Inc. [1].
The court dismissed with prejudice the defendants named Medtronic, Medtronic Sofamor Danek and Medtronic Spinal & Biologics, which it found are not legal entities. It is an individual case, and no MDL covers the system.
July 9, 2018: Medtronic Starts Screw Removal
On July 9, 2018, Medtronic Sofamor Danek began a voluntary removal of 47 units of a CD Horizon multiaxial screw lot. The screws were marked 5.5 mm but were actually 5.0 mm. This is recall Z-2603-2018.
August 10, 2010: FDA Terminates Agile Device Recall
On August 10, 2010, FDA terminated Class 2 recall Z-1417-2008 for the CD Horizon Agile dynamic stabilization device, closing the Agile device recall [2].
September 11, 2008: FDA Posts Agile Device Recall
On September 11, 2008, FDA posted the recall of 105 units of the CD Horizon Agile dynamic stabilization device. The recall was for shear failure of its cable component.
November 12, 2007: Medtronic Begins Agile Recall
On November 12, 2007, Medtronic Sofamor Danek began the recall of the CD Horizon Agile dynamic stabilization device. The FDA record recommends patient monitoring.
Letters went to hospital risk managers and surgeons on December 12, 2007, as part of the recall that FDA later posted as Z-1417-2008.
What Is the CD Horizon Spinal System?
According to the FDA screw recall record, the Medtronic CD Horizon Spinal System “is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine” [3].
The system is a set of implants that includes the Agile dynamic stabilization device and multiaxial screws. Both of those parts have FDA recall records, covered on this page.
Who May Be Affected?
You may be affected if you received a CD Horizon Agile dynamic stabilization device, REF 7901500. The recall covered all codes of this device, with 105 units sold worldwide, including the USA and Canada.
You may also be affected if you received a CD Horizon multiaxial screw for 5.5/6.0 mm rods, REF 55840005045, lot 0648247W. It was a lot of 47 units shipped inside the US.
Spinal fusion patients who had a CD Horizon fixation system implanted with Infuse Bone Graft and PEEK devices have the circumstances alleged in Jones.
Whether you can file a claim depends on an individual legal review. Your surgeon’s implant record shows which device and lot you received.
Reported Injuries or Damages
FDA recall records are the key regulator findings. The Agile device record cites “Breaks: Shear failure of the cable component of the system.” The screw record cites a size mislabel. They state no injury counts.
In Jones, the plaintiff alleges Infuse Bone Graft was used with PEEK devices not meant for it. She alleges the devices “migrate, subside and are expulsed” and her spine failed to fuse.
She also alleges “a myriad of physical ailments.” A CD Horizon fixation system was implanted too. The order rules on a motion to dismiss and makes no finding on these claims. No court record names a CD Horizon defect.
Recall and Regulatory Background
A recall does not prove liability, and it does not mean every patient with the system was harmed. For the screw lot, the notice told customers to locate and remove the impacted product from normal storage locations.
Evidence to Preserve
Keep these items together in one safe place, because they help a lawyer review what happened:
- Implant records showing the product name, REF number, lot number and serial number of each device
- Operative reports and the name of the surgeon who placed the implant in your spine
- Imaging, such as X-rays and scans, taken before and after your spinal fusion surgery
- Medical records and bills for treatment related to the implant, including follow-up visits
- Photographs of scars, swelling or any visible problem, with the date each was taken
- Any recall or hospital notice letters you received about the device, kept with their envelopes
- A log of your symptoms and the work you missed because of them
Filing Deadlines
Deadlines to file an injury claim come from state law. They depend on where you live and when the injury and its cause were discovered or diagnosed.
In some states the clock starts at diagnosis. Filing after the cutoff can end your claim, whatever the evidence shows. Ask a lawyer soon which deadline fits your situation.
Frequently Asked Questions
What Are the Side Effects of the Medtronic CD Horizon Spinal System?
The side effects of the Medtronic CD Horizon Spinal System are not listed in FDA recall records. The only alleged ailments appear in the Jones order, reported at 411 F.Supp.3d 521. Your surgeon can explain risks for your own implant.
Has the CD Horizon Spinal System Been Recalled?
The CD Horizon Spinal System has been recalled in two parts. The Agile device went to the USA, Canada, India, Venezuela, the Netherlands, Chile, Brazil and Australia, while the screw lot went only to the US.
What Does the Research Say About CD Horizon Complications?
The research on CD Horizon complications comes from two FDA recall records. FDA determined the cause of the Agile device recall as “Device Design” and of the screw lot recall as “Employee error.” Those findings describe the recalls, not patient outcomes.
Who Is the Plaintiff in the Jones Case?
The plaintiff in the Jones case is a patient who had three spinal fusion surgeries on October 26 and 27, 2010 in Dallas, Texas. She alleges four Clydesdale devices and one Capstone device were used with Infuse Bone Graft.