Dynesys LIS System, Dynesys Top-Loading System & Zimmer DTO System
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
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.