The DePuy Synthes Craniomaxillofacial (CMF) Distraction System is an implant used to lengthen and/or stabilize the lower jawbone (mandibular body) and the side of the lower jaw (ramus). This device is used in pediatric and adult patients to correct congenital or post-traumatic defects of the jaw by gradually lengthening the bone in a process known as distraction.
The manufacturer, DePuy Synthes, is recalling certain lots of the Craniomaxillofacial Distraction System because the device may reverse direction and lose the desired distraction distance after surgery. In the presence of inadequate distraction or reversal of a previously achieved distraction distance, the patient may need to undergo prolonged distraction therapy. In some instances, revision surgery may be needed to replace the device.
In most cases, due to frequent routine screening, failure to advance would be detected and permanent impairment would not be anticipated. Reversing occurs when the distractor screw is turned in the opposite direction to cause the assembly to lose distraction distance.
There have been 15 reports of injury associated with the use of this device. There is the potential for those patients with an already compromised mandible anatomy to be at higher risk of partial or complete airway obstruction. 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. Children or adults with the ability to maintain an open airway are at less risk for serious injury because failure of the device would not result in tracheal obstruction and could be medically reversible.
The DePuy Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies) is also called an External Mandibular Fixator And/Or Distractor and a Bone Plate. These were manufactured from April 20, 2009, through April 15, 2011, and distributed from November 3, 2009, to April 14, 2014.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall