What is Precice Stryde Lawsuit?
There are many reported cases where patients implanted with a Precice Stryde device experienced intolerable pain and bone changes.
According to https://www.schmidtandclark.com/precice-stryde-lawsuit, the FDA suspected that this event is related to biocompatibility issues with regards to stainless steel and titanium-based Precice products. The said devices are generally used to lengthen, shorten, or compress a limb. It is also used to transform segments of a patient’s long bone.
What is Biocompatibility?
Medical product biocompatibility simply means that the materials and their components are designed to interact with the human body. It should also have its proper biological responses. Every medical device that comes in contact with the human body, whether direct or indirect, is required to undergo a series of testings to ensure biocompatibility. This is to double-check the overall safety and quality of the product.
What are the Side Effects of Bio-incompatibility?
If biocompatibility is absent in a medical device, it could cause harm to people. In the worst cases, it can even lead to death. The list below is composed of common complications arising from bio-incompatibility.
- Intolerable pain
- Bone dislocations and abnormalities
- Cancer, commonly of the bone
- Developmental issues
- Reproductive health issues
- Acute skin irritation
Are All Precice Medical Devices Defective?
Of course, not all of the systems that they offer are faulty. You may be eligible to file a case if you are implanted with one of the products below:
- Precice Stryde
- Precice Bone Transport
- Precice Plate
- Precice Freedom
- Precice Short
- Precice Unyte
- Precice Intramedullary Limb Lengthening (IMLL) Device
Who can File a Case Against NuVasive?
NuVasive Specialized Orthopedic, Inc. announced an urgent advisory about the recall of their specific Precice® System medical devices. If you are implanted with any of the lists above, you may be entitled to sue for damages. You can reach out to Schmidt & Clark, LLP for more lawful details.
The big announcement happened in February 2021. After that, the voluntary recall was immediately implemented in April 2021. On July 8, 2021, the FDA emphasized concerns regarding patients who may be affected by this negligence. Hence, the organization urged health care providers to monitor their patients very carefully.
Everyone is entitled to file a case if:
- You are implanted with one Precice system listed above
- Your device was implanted during 2013 or after
- You are at least 18 years old. Otherwise, guardians are required to represent on your behalf.
- Your device was adjusted using medical magnets or other external remote control.
What is Medical Device Product Liability?
Product liability leads to a personal injury lawsuit due to a defective medical device. This happens when:
- Medical devices are defectively manufactured
- Medical devices are properly manufactured but with a defective design
- Medical devices are wrongfully marketed
Medical devices are defectively manufactured. Obviously, these are the products that were improperly made by the manufacturing company. Sometimes, these are damaged before reaching the patient because of errors in manufacturing and negligence in shipment. Damage may also occur at the hospital or doctor’s office. Simply saying, any defect that occurs between the factory and the receiving place of medical devices is crucial. It is expected that the quality of any medical device can stand handling and weather issues.
Medical devices are properly manufactured but with a defective design. Even though a medical device is properly manufactured, it doesn’t mean that it’s perfect. There are certain instances where the design or prototype from which a product is based is already faulty in the first place. Most of the time, the medical device is on the market for quite some months or years before users report serious injuries.
Medical devices are wrongfully marketed. False marketing typically becomes the bait of big corporations. Any recommendation or instruction concerning the usage or purpose of a medical device is considered marketing. Major companies should know that there should be no “extra” flowery words to be used to describe the function of a medical device. Those “advice” from a hospital, doctor, or sales representative are taken as genuine by the general public. Sometimes, they are also just victims of the manufacturer itself. Hence, a patient may never have encountered any advertisement with regards to the devices used for his/her health. Some people are surely responsible for this.
Learn more about product liability to protect you and your loved ones.