The Charite artificial spinal disc, manufactured by Johnson & Johnson, will be “tweaked” by the manufacturer.

A J&J spokesman says the problem is not with the clinical efficacy of the Charite, but with Medicare reimbursement. They state that a lack of clinical data regarding Charite’s performance has resulted in problems with Medicare payment.

But some surgeons have stated that the design is flawed. Complaints about a faulty center of rotation and post surgical problems with the implant have been reported. In a Congressional hearing, ethical conflicts associated with surgeons receiving payment from manufacturers were discussed.

The Charite is composed of two cobalt chromium endplates that are surgically attached to the vertebrae of the diseased segment. The native disc is removed, and a flexible polyethylene core is inserted between the plates. The core is designed to replace the diseased disc and allow for separation of the vertebrae, normal range of motion and flexibility of the spine.

The product was the first of its kind on the market when released. A competing product manufactured by Synthes Inc is similar in design.

Source: Reuters
http://www.reuters.com/article/email/idUSN0626513720080307