SeaSpine Inc. recalled the Cardiff Anterior Cervical Plate System in April 2010. This metal plate is used in spinal fusion surgery in the neck. Unfortunately, it has been linked to more than a dozen cases in which bone screws backed out, clips broke or bent, vertebrae fused improperly, or patients required revision surgery.
What is the Cardiff Anterior Cervical Plate System?
The Cardiff Anterior Cervical Plate (ACP) System is a medical device used in spinal fusion surgery in the neck (cervical vertebrae). The ACP System consists of a metal plate made of Titanium and Nitinol that is screwed into the patient’s spine in several places. It is intended to temporarily stabilize the spine while vertebrae fuse together.
The Cardiff ACP System is approved to treat:
- degenerative disc disease
- trauma (including fracture or dislocation)
- spinal stenosis
- cervical myelopathy
- deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- failed previous fusion
FDA 510(k) Approval of Cardiff Anterior Cervical Plate System
The U.S. Food and Drug Administration (FDA) approved the Cardiff ACP System in January 2012 under the 510(k) approval process (click here to read the 510(k) approval notification). This process allows manufacturers of new devices to avoid conducting rigorous safety studies so long as the new device is “substantially equivalent” to a device that is already on the market. The approval was based on another Cardiff ACP System and the Sonoma ACP System.
What is the problem with Cardiff Anterior Cervical Plate System?
Problems with the Cardiff ACP System include:
- Bone screws backing out of the metal plate
- Locking mechanism may fit loosely and does not sit naturally in the maximum locking position
- Variability of some screws
- Clips bending and breaking during functionality testing
- Bone screw angulation during implantation
- And more
When complications occur, they may cause a patient’s vertebrae to fuse improperly. Treatment for this complication involves revision surgery to remove and replace the defective device and implant a different device.
SeaSpine Recalls Cardiff Anterior Cervical Plate System
In April 2010, SeaSpine recalled the Cardiff devices after incidents involving significant design and manufacturing defects. SeaSpine and the FDA reported receiving at least 13 complaints from the FDA involving clips bending or breaking, bone screws that backed out of the plate after surgery, and more. SeaSpine has also produced at least 11 product complaints that were submitted before they removed the Cardiff device from the market.