Calaxo bone screw used in ACL repair As advances in medical device technology for the general public is sometimes used as Guinea pigs. Even if we have the FDA to our side, there are many devices on the market that may not have been through appropriate tests.
Take a look at a fairly new product from knee surgery, Smith & Nephew Endoscopy Division, marketed and known osteoconductive interference screw Calaxo. It is also commonly called the Calaxo bone screw.
This product is used for ACL reconstruction. ACL injuries are common and associated with athletes and nonathletes. Any person who, bike, play tennis or organized sports may experience ACL injuries. 80% of ACL injuries are non-contact, which means that the person may have injured themselves by simply standing, turning or landing wrong. Typical response of the victim is "My knee just gave out".
When an ACL (anterior cruciate ligament) tear the tendon above the knee is separated from the bones of the knee. Surgery is a common solution ACL tears still do not necessarily need surgery. The medical community is debating whether or not to invasive surgery.
The risks of ACL surgery include infection, pain in the knee instability persists, a stiff knee joint, and difficulty returning to previous level of activity. Current estimates show that 90% of patients had no complications of ACL surgery.
The Calaxo Bone screw is used to help transplant the ACL security. The main feature of this product is that it does not need to be removed. The screw is simply dissolved in the surrounding tissue. The average time to dissolve is approximately 12 months.
This product also contains chemicals that according to the manufacturer "Our osteoconductive interference screw CALAXO is formulated with chemicals that stimulate the bone surface in the tunnel and trigger the development of new bone, which over time replaces implant. It is preferable to restore the bone tissue that was removed to make room for the transplant. CALAXO makes this possible. "
The problems associated with bone screws Calaxo are numerous. It is possible that the bone can grow on the screw that may interfere with the healing of the ACL. Other problems include swelling of the knee, persistent pain in the knee area.
These side effects and problems have been noted by Smith & Nephew and they issued a recall of the device. Not only Smith & Nephew action, but the legal community has also questioned the device and we see a plethora of law firms investigating problems and injuries related to medical device. There may be a potentially important class action in the immediate future.
Posted on March 12, 2010.