DePuy has recalled a jaw implant after receiving 15 reports of it reversing direction and causing injuries. DePuy is concerned that it could obstruct the airway of an infant, resulting in respiratory arrest, choking, and death. Patients may also need additional surgery to correct complications.
Need a Texas Jaw Implant Injury Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by the DePuy Craniomaxillofacial Distraction System, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Overview
DePuy Synthes manufactures a jaw implant known as the Craniomaxillofacial (CMF) Distraction System. It is an implant that is attached to a patient’s lower jaw (mandible) to lengthen and/or stabilize the bone. It is used in babies with birth defects and children and adults with traumatic injuries to the jaw. It works by gradually lengthening the bone (distraction).
Other names for this jaw implant include:
- External Mandibular Fixator
- External Mandibular Distractor
- Bone plate
FDA Issues Jaw Implant Recall
August 28, 2014 — The FDA has issued a Class I recall for the DePuy Synthes Craniomaxillofacial Distraction System after receiving 15 injury reports. According to the FDA:
“Infants are at the highest risk for injury if the device fails because sudden obstruction of the trachea can occur. This could lead to respiratory arrest, and result in death.”
What is the problem?
According to Urgent Notice (PDF) issued by DePuy on April 16, the problem is that the device can reverse direction after surgery.
The problem occurs when the distractor screw is turned in the opposite direction. This could result in a loss of distraction distance. In most cases, the problem will be detected during routing screening and long-term injuries are not anticipated. However, patients may have to undergo prolonged treatment and they may need additional surgery.
What is the Risk?
Infants have the highest risk of injury. When the device fails, it can obstruct the trachea (throat) and cause respiratory arrest, airway obstruction, choking, and death. Children or adults are less likely to be injured if they can maintain an open airway. In all patients, failure of this device may need to be treated with surgery to replace the implant.
Need a Jaw Implant Injury Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas jaw implant injury lawyers for a free lawsuit review.
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