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Cardiff Anterior Cervical Plate System Lawsuit

The Cardiff Anterior Cervical Plate (ACP) System, a device used to stabilize the spine and promote bone fusion after spinal discectomy surgeries, was recalled in April 2010 after it was found to have significant design and manufacturing defects. Patients implanted with the Cardiff ACP have required painful revision surgeries after the screws of the device backed out of place, resulting in the bone not fusing together properly. To date, the U.S. Food & Drug Administration (FDA) has received dozens of reports of the system’s clips breaking and/or screws backing out of the plate after surgery, many of which occurred well in advance of the device being pulled off the market.

Free Cardiff Anterior Cervical Plate System Lawsuit Evaluation: If you or a loved one suffered a serious injury after being implanted with a Cardiff Anterior Cervical Plate System, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the Cardiff Anterior Cervical Plate System and we can help.

What is the Cardiff Anterior Cervical Plate System?

Manufactured and marketed by SeaSpine, Inc., the Cardiff Anterior Cervical Plate (ACP) System is a temporary implant designed to support the spine during the development of cervical spinal fusion. The device is manufactured from Titanium and Nitinol alloys, and consists of a number of bone plates, screws, and associated instruments. The ACP is indicated for use in patients with:

  • degenerative disc disease
  • trauma (including fracture or dislocation)
  • spinal stenosis
  • cervical myelopathy
  • deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
  • tumor
  • pseudoarthrosis
  • failed previous fusion

The Cardiff Anterior Cervical Plate System was submitted to the FDA for approval under the controversial 510(k) submission process, which means that it was not required to undergo preclinical or clinical trials because it was found to be ‘substantially equivalent’ to other cervical plate systems already on the market.

Cardiff ACP Complications

The Cardiff Anterior Cervical Plate System had a number of serious design and manufacturing defects before it was ever approved by the FDA. The problems with the Cardiff ACP included:

  • issues with the locking mechanism fitting loosely and not sitting naturally in the maximum locking position
  • variability of screws
  • clips bending and breaking during testing
  • problems with screw angulation during implantation procedures

These problems result in screws backing out of the plate, which causes the bone not to fuse properly, and may require one or more painful revision surgeries to correct the problem. To date, at least 13 adverse event reports have been submitted to the FDA concerning the Cardiff Anterior Cervical Plate System, all of which involved the device’s clips breaking and/or screws backing out of the plate after being implanted. Additionally, during the discovery process, SeaSpine produced 11 product complaints that occurred well before the company decided to recall the ACP.

Do I Have a Cardiff Anterior Cervical Plate System Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Cardiff Anterior Cervical Plate System lawsuits. We are handling individual litigation nationwide and currently accepting new Cardiff Anterior Cervical Plate System injury cases in all 50 states.

Free Cardiff Anterior Cervical Plate System Lawsuit Evaluation: If you or a loved one suffered a serious injury after being implanted with a Cardiff Anterior Cervical Plate System, you should contact our law firm immediately. You may be entitled to compensation by filing a Cardiff Anterior Cervical Plate System suit and we can help.

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