Device Description
The ROI-C Implant System and ROI-C Titanium-Coated Implant System
consist of ˊDˊ shaped spacers (or interbodies or cages) in a variety
of footprints and heights. The lordotic shape of the ROI-C Lordotic
Implants & ROI-C Lordotic Titanium-Coated Implants allow for
optimum surface area contact with vertebrae that embody a flat surface
morphology. The curved shape of the ROI-C Anatomic Implants &
ROI-C Anatomic Titanium-Coated Implants allow for optimum surface area
contact with vertebrae that embody a curved surface morphology. The
ROI-C Implant System & ROI-C Titanium-Coated Implant System are
offered in a closed graft space design. The implants feature an
enclosed chamber intended to be filled with autologous or allogenic
bone graft composed of cancellous and/or corticocancellous bone graft.
The superior and inferior surfaces of the implants have a pattern of
teeth to provide increased stability and to help prevent movement of
the device.
The ROI-C Titanium-Coated Implant System offers a porous plasma
sprayed Titanium Coating of superior and inferior surfaces of the implants.
The ROI-C Implant System & ROI-C Coated Implant System are
inserted singularly via an anterior approach and are intended to be
used with autologous bone graft. The devices must be used with
supplemental internal fixation. The ROI-C Implant System & ROI-C
Titanium-Coated Implant System have been designed to be compatible
with optional supplemental fixation specific for the system. The two
piece VerteBRIDGE Anchor Plate is available and may be used to affix
the ROI-C Implant System & ROI-C Titanium-Coated Implant System
implants to the underlying vertebral bone, and to specifically allow
for the option of a standalone construct. Additional or other
supplemental fixation may be used, as patient needs dictate.
Indications
The ROI-C Implant System & ROI-C Titanium- Coated Implant System
are indicated for use in skeletally mature patients with degenerative
disc disease (DDD) of the cervical spine with accompanying radicular
symptoms at one disc level from C2-T1. DDD is defined as discogenic
pain with degeneration of the disc confirmed by history and
radiographic studies. These patients should have had six weeks of
nonoperative treatment. The ROI-C Implant System & The ROI-C
Coated Implant System implants are to be used with autogenous or
allogenic bone graft composed of cancellous and/or corticocancellous
bone graft and implanted via an open, anterior approach. Supplemental
internal fixation is required to properly utilize this system.
Note: VerteBRIDGE® Plating is the supplemental fixation
designed specifically for the ROI-C cage and can be used in
applications where a stand-alone cervical interbody fusion construct
is appropriate. Additional supplemental fixation options that can be
used with the ROI-C cage (with or without VerteBRIDGE Plating) include
anterior vertebral plating and other fixation devices cleared by the
FDA in the cervical spine.
Contraindications
- Presence of fever or acute, chronic, systemic, or localized
infection.
- Metal sensitivity or allergies to the implant
materials, documented or suspected.
- Severe osteopenia.
- Pregnancy.
- Prior fusion at the level(s) to be
treated.
- Patients unwilling or unable to follow
post-operative care instructions.
- Other medical risks,
anesthetics risks, or surgical conditions which would preclude the
potential benefit of spinal implant surgery.
- Any condition
not described in the indications for use.
Warnings
- Risks associated with general surgery, orthopedic surgery, and
the use of general anesthesia should be explained to the patient
prior to surgery. It is also recommended that the advantages and
disadvantages of surgery, the implants, as well as alternative
treatment methods be explained to the patients.
- Potential
risks associated with the use of this system, which may require
additional surgery, include device component failure (bending,
loosening or fracture), loss of fixation, non-union, fracture of the
vertebra, neurological injury, vascular or visceral injury,
neurological complications, over-distraction, trauma to nerve root
or dura, incorrect implant positioning, implant migration,
pseudoarthrosis, disc height loss (impaction of implant into
vertebral end plates), allergy or inflammation, general adverse
effects related to surgical procedures (e.g. anesthesia, infection),
subsidence, expulsion.
- The device can break if it is
subjected to increased loading associated with delayed union or
non-union. If healing is delayed or does not occur, the implant
could eventually break due to material fatigue. Factors such as the
patient weight, activity level, and compliance to weight bearing or
load bearing instructions, have an effect in the stresses to which
the implant may be subjected, and may affect the longevity of the
implant.
- Patients with previous spinal surgery at the
level(s) to be treated may have different clinical outcomes compared
to those without a previous surgery.
- Discard all damaged or
mishandled implants.
- Under no circumstances may the
implants be re-used. Although the device may appear intact on
removal, internal modification due to the stress and strains placed
on it, or small defects may exist which may lead to fracture of the
implant.
- Implants removed from a patient that contact bodily
tissues or fluids should never be reused at risk of contamination of
the patient.
- Mixing Metal: Some degree of corrosion occurs
on all implanted metal and alloys. Contact of dissimilar metals
(e.g. stainless steels and titanium), however, may accelerate this
corrosion process. The presence of corrosion may accelerate fatigue
fracture of implants and the amount of metal compounds released into
the body system may also increase. Internal fixation devices such as
rods, connectors, screws, hooks, etc., which come into contact with
other metal objects must be made from like or compatible metals.
This is an important consideration when using supplemental fixation,
as required by the indications for use of the ROI-C Implant System
& ROI-C Titanium-Coated Implant System.
- Because
different manufacturers employ different materials, varying
tolerances, manufacturing specification, and differing design
parameters, components of the ROI-C Implant System & ROI-C
Titanium-Coated Implant system should not be used in conjunction
with components from any other manufacturer’s implant systems. Any
such use will negate the responsibility Zimmer Biomet for the
performance of the resulting mixed component implant.
- Any
decision by a surgeon to remove the implanted device should take
into consideration such factors as the risk to the patient of the
additional surgical procedure as well as the difficulty of
removal.
- Implant removal should be followed by adequate
postoperative management to avoid fracture.
Precautions
- Being a technically demanding procedure presenting a risk of
serious injury to the patient, the implantation of intervertebral
body fusion devices or partial vertebral body replacement devices
should be performed only by experienced spine surgeons with specific
training in the use of this system and who have knowledge of the
present instruction for use.
- The surgeon should consider
the location of implantation, the weight of the patient, the
patient’s activity level or general conditions and any other factor
which may have an impact on the performance of the system.
- Patients who smoke have been shown to have an increased risk of
non-unions. Such patients should be advised of this fact and warned
of the potential consequences. If the patient is involved in an
occupation or activity which applies inordinate stress upon the
implant (e.g., substantial walking, running, lifting of significant
loads, or muscle strain), resultant forces can cause failure of the
device.
- In some cases, progression of degenerative disease
may also be so advanced at the time of the implantation that they
may substantially decrease the expected useful life to the device.
In such cases, orthopedic devices may be considered only as a
delaying technique or to provide temporary relief.
- Before
clinical use, the surgeon should thoroughly understand all aspects
of the surgical procedure and limitations of the system. The device
is recommended for use only by surgeons familiar with preoperative
and surgical techniques, cautions and potential risks associated
with such spinal surgery. Knowledge of surgical techniques, proper
reduction, selection and placement of implants, and pre and
post-operative patient management are considerations essential to a
successful surgical outcome.
- Patients should be instructed
in detail about the limitations of the implants, including but not
limited to the impact of excessive loading through patient weight or
activity, and should be taught to govern their activities
accordingly.
- Appropriate selection, placement and fixation of
the spinal system components are critical factors which affect
implant service life. Accordingly, strict adherence to the
indications, contraindications, precautions, and warnings for this
product is essential to potentially maximize service life. (Note:
While proper implant selection can minimize risks, the size and
shape of human bones present limitations on the size, shape, and
strength of implants.)
- Supplemental internal fixation is
required when using the ROI-C Implant System and ROI-C
Titanium-Coated Implant System. The two piece VerteBRIDGE®
Anchor Plate system is available for use with the ROI-C
Implant System & ROI-C Titanium-Coated Implant System, and is
the supplemental fixation as needed and determined by the user. The
instructions for use for any additional supplemental fixation
system(s) should be followed according to the manufacturer’s
guidelines.
- Care must be taken to protect the components from
being marred, nicked or notched as a result of a contact with metal
or abrasive objects. Alterations will produce defects in surface
finish and internal stresses which may become the focal point for
eventual breakage of the implant.
- Inspection and trial
assembly are recommended prior to surgery to determine if the
instruments have been damaged during storage or prior
procedures.
- Sale of this product is restricted to
physicians.
