NuVasive Precice® Lawsuit

NuVasive Specialized Orthopedics, Inc. has issued an urgent advisory and recall of their Precice® System medical devices used in limb lengthening or shortening procedures, fracture fixation, and long bone transports due to biocompatibility concerns, an issue that also affects NuVasive’s MAGEC® device system implants.

If you received a MAGEC or Precice System product and are experiencing pain or bone abnormalities around the device, you may be entitled to compensation — and Sokolove Law may be able to help.

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MAGEC and Precice System Device Recall Lawsuits

Breaking News: NuVasive MAGEC and Precice System Recalls Linked to Biocompatibility Issues

In July 2021, the United States Food and Drug Administration (FDA) expressed potential biocompatibility concerns with NuVasive stainless steel and titanium-based devices, urging health care providers to monitor patients who received their devices until more is known.

NuVasive Product Recall Timeline

February 2020
NuVasive Specialized Orthopedics, Inc. issued an urgent safety notice recalling its MAGEC devices due to the failure of a mechanical component that made the implanted endcap separate from the rod part of the device.

February 2021
NuVasive issued an urgent advisory and recall of their stainless steel-based Precice System devices, after patients implanted with the stainless steel-based Stryde device reported pain and changes in the bone tissue around the device, including bony abnormalities between the nail segments.

April 2021
NuVasive initiated a voluntary recall and manufacturer ship hold on their titanium-based Precice devices as well, since the company doesn’t know the cause of the adverse events in the stainless steel-based products.

At the same time, NuVasive informed health care providers of biocompatibility testing concerns with MAGEC devices and placed all MAGEC products on a global shipping hold.

July 8, 2021
The FDA flagged concerns over biocompatibility with NuVasive Precice devices. The FDA urged health care providers to monitor patients who may be affected.

July 15, 2021
NuVasive lifted the shipping hold on MAGEC device system implants, with the modified MAGEC X being the only device version currently available in the United States.

What Is Biocompatibility?

Medical device biocompatibility refers to how the materials and components of a medical device should interact with your body and its biological responses.

Any medical device that comes in contact with the human body, either directly or indirectly, is required to undergo biocompatibility testing to determine the:

  • Overall safety of the product
  • Potential for adverse biological responses

Side Effects of Bio-incompatibility

When a medical device has not been properly tested for biocompatibility, it could end up causing serious harm.

Complications from a device that’s not biocompatible may include:  

  • Bone abnormalities
  • Pain
  • Cancer
  • Developmental effects
  • Reproductive system effects
  • Skin irritation or burns
  • Thrombosis

“The side effects may be related to corrosion, wear, and previously unanticipated exposure of components that are undergoing biocompatibility testing.”
– U.S. Food and Drug Administration

What Are NuVasive MAGEC and Precice Devices?

NuVasive MAGEC devices are metallic spinal implants designed to:

  • Brace the spine during growth
  • Minimize the progression of scoliosis

On the other hand, the devices composing NuVasive’s Precice System are collectively used for:

  • Limb lengthening or shortening
  • Mal-unions and non-unions
  • Open and closed fracture fixation
  • Pseudoarthrosis
  • Transport of long bones

Affected NuVasive MAGEC Devices

NuVasive’s MAGEC System spinal implants have been found to loosen, fracture, corrode, migrate, or cause pain in patients.

Components of the following NuVasive MAGEC devices have been associated with potential mechanical failures and tissue biocompatibility concerns:

  • MAGEC Spinal Bracing and Distraction System
  • MAGEC 2 Spinal Bracing and Distraction System
  • MAGEC System
  • MAGEC System Model X device
  • MAGEC System Model X rod
  • MAGEC System Rods

Although the MAGEC X is back on the market in the U.S., the FDA and NuVasive continue to investigate the root cause of the issues and evaluate new biocompatibility testing results to assess the impact to patients with these devices.

Affected NuVasive Precice Products

The FDA has expressed biocompatibility concerns with both stainless steel and titanium-based NuVasive Precice medical devices.

Affected stainless steel (Biodur 108)-based Precice devices include:

  • Precice Bone Transport
  • Precice Plate
  • Precice Stryde

Patients who received stainless steel-based Precice devices have reported experiencing pain and changes in the bone and soft tissues surrounding their device, though both the FDA and NuVasive are uncertain of why at this time.

Titanium-based Precice devices include:

  • Precice Freedom
  • Precice Intramedullary Limb Lengthening (IMLL) Device
  • Precice Short
  • Precice Unyte

Although adverse biocompatibility issues have not been linked to titanium-based devices yet, the FDA isn’t sure whether the stainless steel material or something in all Precice devices caused these adverse effects.

As NuVasive continues to investigate the root cause of the issues caused by stainless steel-based devices, the company will also look into how these issues may affect their titanium-based products as well.

NuVasive Lawsuit Settlements and Verdicts

Compensation from a NuVasive lawsuit can come in one of two forms:

  • NuVasive Settlements: A NuVasive settlement can be reached before going to court if the defendant makes you a financial offer, which can help you receive compensation sooner.
  • NuVasive Verdicts: If your case doesn’t settle, a judge and jury will hear your case in court and reach a NuVasive verdict that determines an amount of compensation for your injuries, though there’s no guarantee of compensation.

Get Help Pursuing a NuVasive Settlement

If you have received a NuVasive MAGEC or Precice System device and are experiencing pain or discomfort as a result, you may be entitled to compensation for your injuries — and Sokolove Law may be able to help.

As an established national law firm, Sokolove Law has decades of experience helping clients across the country hold companies accountable for their negligence and pursue compensation in the process. In fact, we’ve recovered over $1.4 Billion on behalf of clients injured by dangerous drugs and medical devices over the last 40 years.

Get a free case review today to see if we may be able to help you too.

NuVasive Lawsuit FAQ

Why was NuVasive Precice recalled?

After patients implanted with the Precice Stryde device reported pain and bone changes, NuVasive Precice System products were recalled due to biocompatibility concerns with both the stainless steel and titanium-based products.

Why was NuVasive MAGEC recalled?

NuVasive MAGEC System devices were recalled after the spinal implants were found to have loosened, fractured, corroded, migrated, or caused pain in patients.

Although the MAGEC X model has returned to the market in the U.S., it is still being monitored by the FDA for safety.

What NuVasive Precice models are affected?

Both stainless steel and titanium-based NuVasive Precice devices are affected by the product recall and potential biocompatibility issues.

The affected NuVasive Precice devices include:

  • Precice Bone Transport
  • Precice Plate
  • Precice Stryde
  • Precice Freedom
  • Precice Intramedullary Limb Lengthening (IMLL) Device
  • Precice Short
  • Precice Unyte

The affected NuVasive MAGEC devices include:

  • MAGEC Spinal Bracing and Distraction System
  • MAGEC 2 Spinal Bracing and Distraction System
  • MAGEC System
  • MAGEC System Model X device
  • MAGEC System Model X rod
  • MAGEC System Rods

What is the NuVasive Precice System used for?

NuVasive Precice System devices are generally used to:

  • Lengthen, shorten, or compress the patient’s limb
  • Transport segments of the patient’s long bones
Author:Sokolove Law Team
Sokolove Law Team

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Last modified: July 23, 2021