INDICATIONS
The Streamline Navigated Instruments are intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT- or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.
CONTRAINDICATIONS
The devices are contraindicated and should not be used including but not limited to, patients with the following:
- Infection in or around the operative site
- Allergy or sensitivity to instrument materials
- Use of incompatible materials or devices from other systems
- Any case not described in the indications for use
The Streamline Navigated Instruments are indicated for spinal surgery and therefore, are only appropriate for use with Medtronic StealthStation S7 system and software version 2.1.0. All other navigation software packages are contraindicated.
Refer to the contraindications for the Streamline TL and Streamline MIS that may be used with these surgical instruments.
WARNINGS
The same medical/ surgical conditions or complications that apply to any surgical procedure may also occur during or following implantation of this device system. The surgeon is responsible for informing the patient of the potential risks associated with treatment, including complications and adverse reactions. The surgeon may need to perform additional surgery to address any complications or adverse reactions, which may or may not be device related.
The safety, effectiveness and performance of the devices have been established for conditions in which the devices are used as intended and when used as identified in the Indications for Use. The performance of the devices has not been evaluated for use that is contrary to the Intended Use, Indications for Use or for use that is contraindicated. Failure to use the devices as indicated could detrimentally affect the performance of their components.
Breakage, slippage, misuse, unintended disassembly of multi-component instruments or mishandling of instruments, such as on sharp edges, may cause injury to the patient or operative personnel and/ or increased operating time.
Improper maintenance, handling, or poor cleaning procedures can render the instrument unsuitable for its intended purpose or even dangerous to the patient or surgical staff. These instruments should be carefully placed on trays, cleaned after each use, and stored in a dry environment.
It is important the surgeon exercises extreme caution when working near vital organs, nerves, or vessels and the forces applied while correcting the position of the instrumentation is not excessive, such that it might cause injury to the patient.
During navigation, it is important to frequently confirm navigational accuracy by touching the tip of the instrument on known anatomical points, including accuracy checkpoints, and comparing the position of the instrument tip in the image with its physical location.
The navigated instrument is a highly accurate and sensitive medical device. Handle it with extreme care. If you drop or otherwise damage it, verify its calibration accuracy. Failure to do so may lead to serious injury to the patient. If the stereotaxic navigation system does not appear to be accurate despite troubleshooting (e.g., resetting the system), do not rely on the navigation system. Please refer to the surgical technique manual for further details.
PRECAUTIONS
Prior to use the surgeon must become familiar with the device system and the surgical procedure. Use surgical instrumentation, accessories, and surgical technique guide provided with this device system.
- When using any surgical stereotaxic instruments, be aware that surgical accuracy should be assessed repeatedly throughout a procedure when using a surgical navigation system by positioning the navigated instrument tip on an identifiable anatomical landmark and comparing the actual tip location to that displayed by the system.
- Be aware that not all surgical instruments are appropriate for surgical navigation. Consider using surgical stereotaxic instruments that are identified as compatible with the surgical navigation system being used. Excessive force applied by instruments to implants can dislodge devices, particularly hooks.
- Extreme care should be taken to ensure that this instrument remains in good working order. During the procedure, correct use of this instrument is extremely important. Instruments should not be bent or damaged in any way. Misuse of instruments resulting in corrosion, “freezing-up”, scratching, loosening, bending, or fracture of any or all sections of an instrument may inhibit or prevent proper function and influence navigation accuracy.
- Do not use this instrument for any action for which it was not intended.
- Regularly review the operational state of all instruments and, if necessary, make use of repair and replacement services.
- To avoid injury or navigation inaccuracy, the instrument should be carefully examined for functionality or damage prior to use. A damaged instrument should not be used. Additional back-up instruments are available in the standard Streamline sets.
- Preoperative and operating procedures, including knowledge of surgical techniques, are important considerations in the successful utilization of the system by the surgeon. Further, the proper selection and the compliance of the patient will greatly affect the results.
- The methods of use of instruments are determined by the user’s experience and training in surgical procedures. A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise the results
- Proper patient selection and operative care are critical to the success of the surgery and avoidance of injury during surgery. Read and follow all other product information supplied by the manufacturer of the implants or the instruments.
- Instruments are subject to damage during use as well as long-term potentially damaging effects such as wear. Damage may result in significant risks to safety and/or inability to function as intended.
- If instruments are damaged or broken during use, metal fragments can be viewed by radiographic assessment. It is the surgeon’s responsibility to carefully consider the risks and benefits of retrieving the fragments.
- If the fragment is retained in the patient, it is recommended that the surgeon advise the patient of specific information regarding the fragment material, including size and location and the potential risks associated with the retained fragment.
See product insert for complete labeling limitations related to this device.
