Indications
The DCI implant is indicated for anterior implantation into the cervical disc space at 1 to 3 levels from C3 to C7 and controls segmental motion in cases of cervical disc herniation, cervical DDD and cervical canal stenosis (central or foraminal) with or without myeloradiculopathy in patients with or without neck pain.
Contraindications
Do not use the DCI implant in cases of:
- Any medical or surgical condition precluding the potential benefit of spinal surgery
- Acute or chronic systemic, spinal or localized infections
- Uncontrolled 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
- Severe mechanical instability
- Osteoporosis
- Significant osteopenia
- Vertebral fractures and/or tumors and at any cervical level that has absence of motion on preoperative flexion/extension radiographs
Safety precautions
- 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 resterilized/used.
- Never use implants that are past their expiration date without resterilizing.
- Do not resterilize implants if they have been contaminated by blood or secretions.
- If the device is resterilized, make sure the product is only packaged and sterilized by qualified or trained staff. Follow the general guidelines and aseptic principles when handling items to be sterilized or sterile items. Devices manufactured from different metals should be processed separately to avoid electrolytic action between the metals. The health care provider must validate that the steam sterilization cycle is effective in their facility since all steam sterilization chambers are unique.
