Litigation SupportBoomerang Spinal FusionClient Industry: Civil LitigationResult: Settlement Background:Operative techniques for fusing an unstable portion of the lumbar spine or immobilizing a painful vertebral motion segment have been in use for many years. Lumbar fusion procedures initially were used to treat patients with infections, such as tuberculosis, or for misaligned spines. Because of the high failure rates associated with early fusion procedures using bone graft or posterior pedicle screws, an eventual transition to more successful approaches to disk height maintenance using a structural graft took place. Tapered fusion cages became favored because fusion success requires, in part, both mechanical stability and adequate graft material to provide a favorable biologic environment in which fusion can occur. It is estimated that more than 300,000 lumbar spine fusion procedures are performed each year in the United States.
The Boomerang is a bow-shaped implant with biconvex surfaces that provide a large opening for graft placement. Advantages of the Boomerang include its transparency to x-rays, lack of artifacts on CT imaging, and transverse positioning within the disk space, producing increased biomechanical stability. However, the Boomerang II also has its downfalls, as they relate to this particular case. Our client represented Plaintiff who had sustained permanent and disabling nerve injury from a surgical procedure that involved a Boomerang cage being inserted into his/her L5-S1 disk space. During installation, the implant slipped out of its holding device as the surgeon was attempting to tap the holder to place the cage in the intended space. This faulty placement caused pain, suffering, and multiple surgeries. Specifically, we were asked to review the documents associated with the case (depositions, drawings, etc) and also inspect and test the subject holder using exemplar cages of various size, and to render an expert opinion on whether the alleged premature release of the cage by the holder could have been caused by defective design and/or manufacturing of the holder device. Inspection and Testing:The subject holder device and three different size Boomerang cages were inspected as each cage was inserted into the holder and the holder was put in the “locked” position. A 16 oz. rubber mallet was used to moderately tap the top of the inserter (about the same force as surgeon). It was observed that the cage would slip out of the holder every time with all three sizes.Opinion: We determined that the prong on the holder was defectively designed with respect to its length and inclination angle. The prong, being inclined at an angle, facilitates the slippage of the cage as it coincides with a similarly oriented hole on the cage. The low stiffness of the cage material also makes it susceptible to deformation due to moderate tapping forces expected during installation procedure, which in turn could result in slippage of the cage. The prongs length and its orientation do not appear to have been appropriately designed to prevent the cage from rotation within the claw and slippage.
An exemplar holding device similar to the Boomerang holding device was designed and manufactured by us to address the above design flaws. A holder was designed and manufactured with a slightly longer prong and the prong’s inclination angle was increased to a near vertical with respect to the adjoining claw portion. This device was effective in securing the cage and preventing the cage from slipping out of the holder based on multiple tests. Conclusion:The subject holder in its designed and as-manufactured condition included a design flaw that results in premature release of the cage when the holder is moderately tapped upon. This design flaw was the producing cause of premature release of the Boomerang cage on the day of the incident at issue in this case, and directly contributed to injuries sustained by Plaintiff. |
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