The DSS Stabilization System is not approved for non-fusion in the U.S.
Indications
The DSS Stabilization System is indicated for skeletally mature patients with degenerative disc disease (DDD) at one to three levels from L1 to S1, including conditions such as grade 1 spondylolisthesis. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies.
Contraindications
Do not use the DSS implant in cases of:
- Any medical or surgical condition precluding the potential benefit of spinal surgery
- Acute or chronic systemic, spin al or localized infections
- Active systemic and metabolic diseases
- Obesity
- Pregnancy
- Dependency on pharmaceutical drugs, drug abuse, or alcoholism
- Lack of patient cooperation
- Foreign body sensitivity to the implant material
- Degenerative spondylolisthesis greater than grade 1 or isthmic spondylolisthesis
- Degenerative scoliosis greater than 25 degrees
- Significant osteopenia
Safety Precautions
- Only stabilize a segment with either dynamic couplers or fusion couplers. Do not use both a dynamic coupler and a fusion coupler at the same level
- Prior to use, thoroughly read these instructions for use and become familiar with the surgical technique.
- Keep the instructions for use accessible to all staff.
- The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the established operating techniques. Proper surgical performance of the implantation is the responsibility of the operating surgeon.
- The manufacturer is not responsible for any complications arising from incorrect diagnosis, choice of incorrect implant, incorrect operating techniques, the
limitations of treatment methods or inadequate asepsis.
- Under no circumstances may modular implant components from different suppliers be combined.
- Each patient’s record shall document the implant used (name, article number, lot number).
- During the postoperative phase, in addition to mobility and muscle training, it is of particular importance that the physician keeps the patient well informed about post-surgical behavioral requirements.
- Damage to the weight-bearing structures can give rise to loosening, dislocation and migration, as well as other complications. To ensure the earliest possible detection of such catalysts of implant dysfunction, the implant must be checked periodically post operative using appropriate techniques.
- Never reuse an implant. Although the implant may appear undamaged, previous stresses may have created non-visible damage that could result in implant failure.
- Never use implants if the packaging is damaged. An implant with damaged packaging might be damaged itself and thus may not be used.
- Never use implants that are past their expiration date.
- Do not resterilize implants.
See product specific surgical technique manual and package insert for complete instructions and labeling limitations.
