The Zimmer Spine SC-AcuFix Anterior Cervical Plate System
components are temporary implants and associated instruments that are
used to stabilize the cervical spine during the development of a solid
spinal fusion in patients with degenerative disease, trauma (including
fractures), and tumor pathology. The SC-AcuFix System
consists of single and multi-segmented titanium bone plates of various
sizes and lengths, titanium bone screws in various diameters and
lengths, and instrumentation for plate insertion. Fixation is provided
by the insertion of bone screws through the two openings at each end
of a plate segment into the vertebral bodies of the cervical spine.
Fixation of the screws to the plate is accomplished by seating into
the SecureRing® screw retention mechanism. Screws may also be inserted
into additional adjacent screw holes of multi-segment plates if needed.
The SC-AcuFix Anterior Cervical Plate System is indicated
for use in the temporary stabilization of the cervical spine (C2-C7)
during the development of solid spinal fusion in patients with
instability caused by the following:
- Degenerative disc disease (DDD) - as defined by neck pain of
discogenic origin with degeneration of the disc confirmed by patient
history and radiographic studies;
- Trauma (including
- Spinal stenosis;
- Deformity (i.e., scoliosis, kyphosis,
- Psedarthrosis; and
- Failed previous
The SC-AcuFix Anterior Cervical Plate System is not designed
or sold for any use except as indicated. Do not use SC-AcuFix
Implants in the presence of any contraindication. Contraindications
include, but are not limited to:
- Presence of overt infection and/or localized
- Rapid joint disease, bone absorption,
osteopenia and/or osteoporosis.
- Suspected or documented
metal allergy or intolerance.
- Any patient having inadequate
tissue coverage over the operative site.
- Any time implant
utilization would interfere with anatomical structures or expedited
physiological performance, such as impinging on vital
- Severe comminuted fractures, such that segments
may not be maintained in satisfactory proximate reduction.
- Use in displaced, non-reduced fractures with bone loss.
- The presence of marked bone absorption or severe metabolic bone
disease that could compromise the fixation achieved.
other medical or surgical condition that would preclude the
potential benefit of surgery, such as elevation of sedimentation
rate unexplained by other diseases, elevation of white blood count
(WBC), fever, leukocytosis or a marked left shift in the WBC
- The physical contact of the
SC-AcuFix System implants with metal implant made of
anything other than implant grade titanium, such as stainless steel
(ASTM F138) or MP35 N, or other dissimilar metal.
- Situations with the absence or compromise of significant
- Use in the presence of any neural or
vascular deficits or other compromising pathology, which may be
further injured by device intervention.
Following are specific warnings, precautions, and adverse effects,
which should be understood by the surgeon and explained to the
patients. These warnings do not include all adverse effects, which can
occur with surgery in general, but are important considerations
particular to metallic internal fixation devices. General surgical
risks should be explained to the patient prior to surgery.
- In the U.S.A., this product has labeling limitations.
- This device is not approved for screw attachment or fixation to
the posterior elements (pedicles) of the cervical, thoracic, or
- Potential risks identified with the use of
this device system, which may require additional surgery,
a) Device component fracture.
b) Loss of
d) Fracture of the
e) Neurological injury.
f) Vascular or
- CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT.
Contouring of the metal implants should only be done with proper
equipment. It is recommended that contouring be gradual and that
great care be used to avoid any notching, scratching or reverse
bending of the devices when contouring. Alterations will produce
defects in surface finish and internal stresses which may become the
focal point for eventual breakage of the implant.
OF THE IMPLANT AFTER HEALING. Metallic implants can loosen,
fracture, corrode, migrate, possibly increase the risk of infection,
cause pain, or stress shield bone even after healing, particularly
in young, active patients. The surgeon should carefully weigh the
risk versus benefits when deciding whether to remove the implant.
Implant removal should be followed by adequate postoperative
management to avoid refracture. If the patient is older and has a
low activity level, the surgeon may choose not to remove the implant
thus eliminating the risk involved with a second surgery.
- ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the
patient’s ability and willingness to follow instructions are one of
the most important aspects of successful bone healing. The patient
must be made aware of the limitations of the implant and follow the
post-operative care regimen as instructed by his or her
- DO NOT ALTER OR MODIFY ANY SC-AcuFix
SYSTEM INSTRUMENT. Repairs should only be accomplished by the
manufacturer. The SC-AcuFix System is only a temporary
implant used for the correction and stabilization of the cervical
spine. A successful result is not achieved in every surgical case.
Bone grafting must be part of the spinal fusion procedure in which
the SC-AcuFix System is used.
- All implants and
some instruments are intended for single use only; refer to the
product label to determine if the instrument is single use only.
Single use devices should not be re-used. Possible risks associated
with re-use of single-use devices include:
- Mechanical malfunction
- Transmission of infectious
Re-operation to remove or replace implants may be required at any
time due to medical reasons or device failure. If corrective action is
not taken, complications may occur.
These complications may include but not be limited to:
- Device corrosion with localized tissue reaction and pain.
- Device migration which may result in injury to soft tissue,
visceral organs or joints.
- Loosening or disassembly of
implant resulting in additional injury.
- Bending, loosening
or breaking of the implant making removal difficult, impractical.or
- Abnormal sensations, discomfort or pain.
- Increased risk of infection.
- Bone loss due to stress
Preoperative and operating procedures including knowledge of
surgical techniques, good reduction, and proper selection and
placement of the implant are important considerations in the
successful utilization of the SC-AcuFix System by the surgeon.
Proper patient selection and the patient’s ability to comply with
physician instructions and follow prescribed treatment regimen will
greatly affect the results. It is important to screen patients and
select optimal therapy given physical and/or mental activity
requirements and/or limitations. If a surgical candidate exhibits any
contraindication or is predisposed to any contraindication, DO NOT USE
the SC-AcuFix System.
Patients who smoke have been shown to have an increased incidence of
non-unions. These patients should be advised of this fact and warned
of this consequence. Patients with poor bone quality are also poor
candidates for surgery.
Occurrence of any adverse effects may require re-operation and
removal of the implant. Adverse effects may include but not be limited to:
- Early or late loosening of the components.
- Disassembly, fretting, loosening, bending, breakage and/or
migration of any component or component portion.
body reaction to the implants.
- Pressure on the skin from
component parts where there is inadequate tissue coverage over the
implant, causing skin irritation.
- Early or late
- Vertebral body fracture at, above, or below the
level of surgery.
- Implants cutting through bone, especially
soft osteoporotic, osteopenic, or cancellous bone.
forming around the implant, making removal difficult or impossible.
- Non-union (pseudarthrosis) or bone fracture.
- Post-operative change in spinal curvature, loss of correction,
height, and/or reduction.
- Neurovascular compromise
including radiculopathy, paralysis, or other types of serious injury
causing pain and disability.
- Hemorrhage of blood
- Cessation of growth of the operated portion of the