INDICATIONS
The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
These patients should be skeletally mature and have had six months of nonoperative treatment. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.
CONTRAINDICATIONS
This device is not intended for cervical spine use. Contraindications include:
- Infection local to the operative site.
- Signs of local inflammation.
- Fever or leukocytosis.
- Morbid obesity.
- Pregnancy.
- Mental illness
POTENTIAL ADVERSE EVENTS
Adverse effects may occur when the device is used either with or without associated instrumentation. The risk of adverse effects as a result of movement and non-stabilization may increase in cases where associated complementary support is not employed. Potential adverse events include:
- Implant migration.
- Breakage of the device(s).
- Foreign body reaction to the implants including possible tumor formation, auto immune disease, and/or scarring.
- Pressure on the surrounding tissues or organs.
- Loss of proper spinal curvature, correction, height, and/or reduction.
- Infection.