The risks of this procedure are the same as with anterior lumbar discectomy and fusion. The difference is that this device is not a fusion. With motion, the device can migrate or wear down. These possibilities are being studied. This device is not released for general use, only as an investigational FDA device.

The procedure is performed in close proximity to the large blood vessels that go to the legs. Damage to these large blood vessels may result in excessive blood loss. Quoted rates in the medical literature put this risk at 1% to 15%. There is also a small risk of injury to the bowel or ureter, since they are in the proximity of the lower lumbar discs.

For males, another risk unique to this approach is that approaching the L5-S1 (lumbar segment 5 and sacral segment 1) disc space from the front has a risk of creating a condition known as retrograde ejaculation.

In males, there is a small risk of retrograde ejaculation with anterior approaches at L5-S1. The nerves that control ejaculation lay over the front of the L5-S1 disc. They are very sensitive, and therefore even with retraction the normal coordination of ejaculation can be disrupted resulting in the ejaculation occurring backward into the bladder. It should be noted that erection and sex drive are not affected. Fortunately, retrograde ejaculation happens in less than 1% of cases (but in some studies is higher) and tends to resolve over time (a few months to a year).

In skilled hands, this is a very safe procedure. Possible reported risks and complications may include, but are not limited to:

• Bleeding
• Retrograde ejaculation (in men)
• Injury to the ureter
• Injury to the bowel
• Incisional hernia
• Damage to nerve roots
• Bleeding
• Continued pain
• Adjacent disc disease
kidney
• Stroke
• Implant extrusion
• Paralysis
• Infection
• Death

After Surgery
Patients are allowed gradually increased activity after the operation. Bracing may be used for one week for comfort, but motion is encouraged. The outcome of this procedure is pending FDA investigational study.