A recall of the DePuy Synthes Craniomaxillofacial (CMF) Distraction System has been issued due to the risk of severe and life-threatening injury if the device reverses direction after implantation. Attorney Group for Kansas is currently offering free case evaluations to clients who believe they are eligible to file a DePuy Synthes jaw implant lawsuit. Call today.
CMF Distraction System
The CMF Distraction System is intended to gradually distract or lengthen the jaw bone, guiding the bone to grow over time. It has been used in both children and adults, but can pose a particularly severe risk of injury or death in infants because infants lack the ability to “breathe around” the device if it malfunctions and blocks their airway. In cases of children with birth defects, a physician will use an osteotome to divide or crack the jaw bone where it is deformed and lock the mesh plates into their proper locations to allow for normal bone distraction. In adults and older children, the CMF Distraction System is often used to treat traumatic injuries like broken jaws following car accidents.
The U.S. Food and Drug Administration (FDA) issued a recall for the devices on August 28, 2014, following at least 15 claims where patients claimed that the implants reversed direction. Not only does this cause the loss of the desired jaw growth, but it could also cause severe or life-threatening problems. Those most at risk are very young children and infants, because sudden device failure can cause the trachea to become obstructed, possibly leading to respiratory arrest or death.
Older children who are fitted with the device may be more likely to maintain an open airway if the device fails. Additionally, while adults may not suffer from tracheal obstruction, device failure may still result in the need for an additional surgical procedure to remove and replace the device. Patients may be required to undergo extended distraction therapy should their devices prematurely fail.
In April 2014, the manufacturer sent an Urgent Notice to its customers to inform them of the issues with the affected products. The company provided instructions to medical providers and hospitals, requesting that they examine their inventory and discontinue use of all devices involved in the recall.
Legal Counsel May Be Beneficial for Patients
Patients who are currently living with the DePuy jaw implant or another type of distractor should be carefully monitored until an imaging or clinical examination indicates an appropriate course of distraction. Physicians should consider examining their patients to determine the severity of any abnormalities, the patient’s caregiving environment in the event of an emergency, and the patient’s ability to protect his or her airway.
Eligible to File a DePuy Synthes Jaw Implant Lawsuit?
Have you or a loved one received the DePuy jaw implant and subsequently suffered from tracheal obstruction, respiratory distress, or other complications? If so, you may be eligible to file a DePuy Synthes jaw implant lawsuit. Contact Attorney Group for Kansas today for a free, no obligation consultation to determine whether you are eligible to recover damages for your injuries. If so, we can connect you with an affiliated attorney in Kansas who can file a DePuy Synthes jaw implant lawsuit on your behalf. Call today.