SeaSpine has received more than a dozen reports of severe complications associated with the Cardiff Anterior Cervical Plate System. The Cardiff ACP System is a metal plate that is screwed into a patient’s vertebrae to help stabilize the area after spinal fusion surgery in the neck. Unfortunately, bone screws can back out, clips can bend or break, vertebrae may fuse improperly, and patients may require revision surgery.
What is the Cardiff Anterior Cervical Plate System?
SeaSpine manufactures the Cardiff Anterior Cervical Plate (ACP) System, which is a metal plate made of Titanium and Nitinol. It comes in many shapes and sizes, but all of the products are screwed into a patient’s cervical vertebrae to provide stabilization after spinal fusion surgery in the neck.
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
SeaSpine manufactures a line of products under the Cardiff brand. One of the most recent approvals was in January 2012, when the U.S. Food and Drug Administration (FDA) approved an application under the 510(k) approval system (click here to read the notice).
The 510(k) system expedites approval by allowing manufacturers of new devices to avoid safety studies if the device is “substantially equivalent” to another device that has been approved. SeaSpine based their most recent 510(k) application on another Cardiff ACP System and the Sonoma ACP System.
What is the problem with Cardiff Anterior Cervical Plate System?
Cardiff ACP System problems and complications:
- Bone screws can back out of the metal plate.
- The locking mechanism may not fit tightly or sit naturally in the locking position.
- Screw variability.
- Clips can bend and break during functionality testing.
- Bone screw angulation during implantation.
- And more.
These complications can cause a patient’s spine to fuse improperly. They may require revision surgery to remove and replace their defective implant. This can prolong healing and recovery time and potentially lead to long-term complications.
SeaSpine Recalls Cardiff Anterior Cervical Plate System
SeaSpine recalled the Cardiff ACP System in April 2010 after receiving reports indicating serious design and manufacturing defects. The FDA and SeaSpine have received at least 13 complaints of broken or bent clips and bone screws backing out. However, SeaSpine received at least 11 complaints before the Cardiff ACP was withdrawn from the market.