DePuy Synthes Craniomaxillofacial Distraction System
DePuy Synthes Craniomaxillofacial Distraction Systems helps lengthen or stabilize the lower jawbones. Surgeons implant this system into patients who have suffered trauma or who were born with congenital birth jawbone defects. When surgeons install the system properly, the system will slowly gradually expand the length of the jaw bone. The large medical company Johnson & Johnson owns DePuy Synthes, which manufactures the DePuy Synthes Craniomaxillofacial Distraction System.Safety Concerns With the DePuy Synthes Craniomaxillofacial Distraction System
The FDA issued a Safety Communication that warned doctors and patients that the DePuy Synthes Craniomaxillofacial Distraction System had a defective design. In this safety warning, the Food and Drug Administration (FDA) gave the system a Class 1 product recall announcement. In the announcement, the FDA stated that infants who undergo the procedure could experience a dangerous sudden obstruction of the trachea. This obstruction can result in an infant experiencing respiratory failure and even cause the child's wrongful death.
In an August 8, 2014 decision, the FDA announced the recall. On August 16, 2014, Depuy Synthes sent their customers an Urgent Notice that warned them about the design defect of their product. They also discussed the potential that their system could cause patients serious harm. Specifically, they stated that the system could reverse its direction unexpectedly. As a result, the device could lose distraction distance after a surgeon installs the device.Which Products Were Recalled?
Every DePuy Synthes Craniomaxillofacial Distraction System made between April 20, 2009, and April 15, 2011, has been recalled with the authority of the FDA. Unfortunately, many DePuy Synthes Craniomaxillofacial Distraction System devices remained available for purchase until April 14, 2014. Two days later, the company sent another notice to hospitals, patients, doctors, or medical centers.How Many Injuries Have Happened due to This Device?
As far as we know, there have been at least 15 known cases of serious injuries related to the DePuy Synthes Craniomaxillofacial Distraction System. These cases are the ones that people have reported to the FDA, and they required replacement of the device or other types of surgical intervention. Johnson & Johnson has faced Class 1 recalls before for other products. Since 2012, the FDA has recalled 12 of the company's products, removing them from the medical marketplace.
Medical offices and hospitals that received the recall notice have a duty to check their medical inventory and remove every recalled distractor from their current stock, particularly, the BC and AB distractor bodies. If your medical provider failed to remove these defective products from their supply and used one after they had been recalled, you might be entitled to compensation in a personal injury lawsuit.Potential Complications From the Craniomaxillofacial Distraction System
According to the FDA, the DePuy Synthes Craniomaxillofacial Distraction System needed to be recalled because of the following possible complications, including:
- Unexpected obstruction of the trachea in infants, children, and adults. This obstruction can cause respiratory failure and even death, especially in infants under 1 year old
- The medical device itself can fail to allow the patient to keep their airways open, in a way that does not cause a tracheal obstruction but still does damage
- The medical device can fail to lead to surgical intervention, requiring the failed device to be replaced
Surgeons have a duty to monitor their patients who have received implanted distractors. This duty includes taking images and engaging in skillful clinical evaluations to confirm whether or not there is a problem. DuPuy Synthes and the FDA have requested that doctors request appointments with their patients who might not be aware of any abnormalities with their DePuy Synthes Craniomaxillofacial Distraction Systems. If a doctor knew about the recall and failed to reach out to a patient with the system, they could be liable for the patient's injuries.Seeking Legal Representation Related to Your Injuries
If you or a loved one have suffered an injury due to the DePuy Synthes Craniomaxillofacial Distraction System, you might be entitled to legal damages. At Arnold & Smith, PLLC, we have the experience you need to advocate effectively for your right to compensation. Our Charlotte medical malpractice lawyers have the legal experience and the resources needed to handle cases involving defective medical devices.
We can help you build an effective case showing that the manufacturer failed to protect consumers from dangerous complications. We might also be able to show that your medical provider failed to provide you with adequate treatment. Contact us today to schedule your free case evaluation.