LIS System, Dynesys Top-Loading System & Zimmer
Only experienced spinal surgeons with specific training in the use
of the Dynesys Spinal System, the Zimmer DTO Implant
and the OPTIMA ZS Spinal system should perform the
implantation of these systems. This is due to the technically
demanding procedure presenting a risk of serious injury to the
patient. These systems should only be used with instrumentation
specifically designed for each system. Refer to the respective
surgical techniques to determine which instruments should be used for
each step of the surgical procedure.
Unless the Zimmer DTO Implant is being used, components of
spinal fixation systems other than Zimmer Companies should not be used
with the components of the Dynesys Spinal System. Only the
OPTIMA ZS Spinal System, including the OPTIMA
ZS Transition Screw, may be used in combination with
the Zimmer DTO Implant.
No component of the Dynesys Spinal System and the
Zimmer DTO Implant should be reused or re-sterilized.
The Dynesys Spinal System and the Zimmer DTO
Implant are intended to be used with bone graft, which is
required to provide additional spinal support. A successful result is
not always achieved in every surgical case.
The patients should be made aware that a successful result, as
defined by reduced pain, increased function and the establishment of
solid fusion, is not always achieved in every surgical case. Proper
patient selection will greatly affect the results. Patients who smoke
have been shown to have an increased incidence of non-union. These
patients should be informed of this increased risk and counselled to
discontinue tobacco use prior to and immediately after surgery. Obese,
malnourished, and/or alcohol abuse patients are also poor candidates
for spinal fusion. Patients with poor muscle tone and bone quality,
and/or nerve paralysis are also poor candidates for spinal fusion. The
use of autogenous bone graft has been shown to provide superior
results compared to the use of allograft bone graft material.
In addition to the above specified warnings and precautions, general
surgical risks should be explained to the patient prior to surgery.