OpenJurist

Calaxo Bone Screw Pain, Fluid Buildup and Screw Fragmentation

The Calaxo Bone Screw is a medical device designed to promote bone growth and density. The device has endured massive scrutiny after a recall was issued in late 2007. Patients were reporting pain, fluid buildup and screw fragmentation. Since the recall, many plaintiffs have commenced lawsuits to seek compensation for medical costs associated with use of the Calaxo Bone Screw.

The Calaxo Bone Screw was approved for use as a medical device in March, 2006. It is designed for use after reconstructive surgery of the Anterior Cruciate Ligament (ACL) which runs from the shin bone to the knee joint and thigh bone. This is a common surgery in those involved in athletics as the ACL is commonly ruptured after quick side-to-side movements. The surgery requires the drilling of holes in the shin bone and the re-attachment of the ACL to its proper location in the leg with the use of bone screws such as the Calaxo design. In addition to anchoring the ACL to the bones in the leg, the chemical makeup of the Calaxo product was designed to dissolve in the body and avoid further painful surgeries for the patient in the future.

Soon after the device was introduced, patients began complaining of severe swelling, redness and joint tenderness. Some patients required subsequent surgeries to remedy dead or infected tissue. Fluid pockets were forming around the implantation site and the product was immediately recalled by the FDA and other foreign regulatory agencies.

Since the recall, litigation has flooded courts in many jurisdictions by plaintiffs eager to recover for their pain and suffering as a result of injuries sustained from the Calaxo Bone Screw. The device is manufactured by the endoscopy division of Smith & Nephew, Inc.

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