Weitz & Luxenberg today opened an investigation into a dental implant suspected of putting infants at risk of respiratory arrest and death.
The investigation comes on the heels of news that certain lots of this device —the DePuy Synthes Craniomaxillofacial Distraction System —have been recalled, according to the U.S. Food and Drug Administration.
The Class I recall was prompted by fears that the DePuy Synthes CMF Distraction System from the affected lots can trigger respiratory arrest and death in infants.
Class I recalls are the most serious type of recall. They are issued when there exists “a reasonable probability that use of these products will cause serious adverse health consequences or death,” the FDA indicates.
According to the FDA, there have been 15 reported cases of injury associated with the DePuy Synthes CMF Distraction System.
The recall was initiated voluntarily by the manufacturer, West Chester, PA,-based DePuy Synthes. It affects 200 lots of the DePuy CMF Distraction System.
The DePuy Synthes CMF Distraction System is used to correct congenital or trauma-induced defects in both children and adults by gradually lengthening and stabilizing the jawbone.
This allows bone to grow within a gap that the distraction system incrementally widens.
The recalled devices include the Synthes AB and BC Distractor Bodies. According to the FDA, the device is sometimes also called the “External Mandibular Fixator and/or Distractor and a Bone Plate.”
In the recalled lots, the DePuy Synthes CMF Distraction System was found to sometimes reverse direction after surgery.
This reversal prevents the DePuy Synthes CMF Distraction System from correcting and stabilizing the jaw.
Far more ominously, it has the potential to cause infants to suffer a sudden obstruction of the trachea.
The DePuy Synthes CMF Distraction System is a Class II medical device. The FDA approved it through its 510(k) process in 2006.
In the documents DePuy Synthes submitted to the FDA at that time, the company described its product as being a modular family of internal distraction osteogenesis devices.
In announcing the recall, DePuy Synthes issued a letter on April 16 to dentists, oral surgeons, and other treatment specialists who it knew had acquired the DePuy Synthes CMF Distraction System.
The letter warned that, “[i]n 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.”
The company explained that, should the screw holding the distractor turn in the opposite direction, it could cause the assembly to lose distraction distance.
This would permit the reversal to occur, the DePuy Synthes recall letter indicated.
“There is the potential for those patients with an already compromised mandible anatomy to be at higher risk of partial or complete airway obstruction,” the letter stated.
“To mitigate the risk of a distractor reversal, patients should be closely followed until a clinical and/or imaging examination confirms the desired outcome,” it went on to advise.