KALAMAZOO, Mich. — Orthopedic giant Stryker is hoping a new medical device will ease the pain from its disastrous release of the OASYS Midline Occipital Plate.
Stryker, a Kalamazoo-based medical device manufacturer, has officially received 510(k) clearance from the U.S. Food and Drug Administration for its Tritanium PL Posterior Lumbar Cage, designed to assist patients with degenerative disk disease by fixating the lumbar spine.
The intervertebral body fusion devices are manufactured via a 3D additive manufacturing process in an effort to make it easier to implant and use in conjunction with a bone graft or artificial bone growth device.
Tritanium is a proprietary porous metal that promotes biologic fixation and bone in-growth in spine applications.
The large lateral windows and open architecture of the Tritanium PL Cage allow visualization of fusion on CT and X-ray. Its solid-tipped, precisely angled serrations are designed for bidirectional fixation and to maximize surface area for endplate contact with the implant. The Tritanium PL Cage is also designed to address the potential for subsidence into the endplates.
“We are pleased to bring this technology to our spine surgeon community and their patients,” said Brad Paddock, President of Stryker’s spine division.
The device is expected to be available in the second quarter of 2016.
OASYS Midline Occipital Plate
Stryker’s prior foray into the spinal fusion market lasted only about three years, because the FDA issued an urgent recall of the OASYS Midline Occipital Plate in February 2013. Unfortunately, by that time, thousands of these dangerous devices had already been implanted.
This gadget was screwed to the back of the skull during some spinal fusion surgeries. The device contained multiple components, and a key pin that connected the body with the head was prone to failure.
Initially, patients experienced pain and muscle weakness in the upper spine and in the shoulders. Later, as the loose metal begins to grind against bone and nerves, there is serious blood loss and nerve damage. Eventually, patients need painful revision surgery to correct the damage.
Our Defective Medical Device Lawyers Can Help
Our defective medical device attorneys can help if you or someone you care about was injured during or after a procedure involving a OASYS Midline Plate. Lawsuits have been filed against the device makers by both patients and their families seeking compensation for injuries caused by the defective medical device. You may be entitled to a settlement.
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