FDA Falls Asleep in Reporting Faulty Surgical Device

The FDA’s Medwatch program is supposed to enhance patient safety by publicizing adverse medical events, but you have to wonder how effective it is when the feds wait more than four months to post a serious problem with a medical device.

Although a recall was issued in mid-April for a faulty jaw implant, it wasn’t until the end of August that the public learned about it on MedWatch.

The surgical device, known as a Craniomaxillofacial (CMF) Distraction System, is used to correct jaw defects. It’s made by DePuy Synthes, which sent its customers an “urgent notice” April 16.

Used in pediatric and adult patients to correct birth defects, or those that occur as a result of trauma, apparently CMF can become unstable, and reverse direction after surgery.

It was a Class I recall, which is the most serious level, defined by the FDA as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

And it took more than four months for us to learn about it?

The FDA said infants are at the highest risk for injury if the device fails, but all patients are at risk, and could need additional surgery to replace a failed implant. So far, 15 reports of injury have been associated with the use of the device.

 


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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