Download DSS Instructions for Use

INSTRUCTIONS FOR USE
DSS™ Stabilization System - Rigid
DSS™ Stabilization System - Slotted
INSTRUCTIONS FOR USE
DSS™ Stabilization System - Rigid
DSS™ Stabilization System - Slotted
UNITED STATES CONTACT
Paradigm Spine LLC 505
Park Avenue, 14th floor
New York, NY 10022 USA
Phone: (888) 273-9897
Fax: (917) 591-6419
MANUFACTURER
Paradigm Spine GmbH
Eisenbahnstrasse 84
78573 Wurmlingen / Germany
Phone: +49 (7461) 963599-0
Fax: +49 (7461) 963599-20
CAUTION
USA Federal law restricts this device to
sale by or on the order of a physician.
Introduction
Like any other temporary internal fixation devices, DSS™
Stabilization System spinal implants have a finite useful
life. The patient’s activity level has a significant impact
on this useful life. Inform your patient that any activity
increases the risk of loosening, bending, or breaking of the
implant components. Instruct patients about postoperative
activity restrictions and examine patients postoperatively
to evaluate the fusion mass development and the implant
status. Even if solid bone fusion occurs, implant components may nevertheless bend, break, or loosen. Therefore,
tell the patient that implant components may bend, break,
or loosen even though restrictions in activity are followed.
Because of the limitations imposed by anatomic considerations and modern surgical materials, metallic implants
cannot be made to last indefinitely. Their purpose is to
provide temporary internal support while the fusion mass
is consolidating. These types of implants are more likely to
fail if no bone graft is used, if a pseudoarthrosis develops,
or if patients have severe or multiple preoperative curves.
You may remove these implants after bone fusion occurs.
Discuss the possibility of a second surgical procedure with
the patient and the risks associated with a second surgical
procedure. If the implants do break, consider the patient’s
condition and the risks associated with the presence of the
broken implant when deciding whether to remove them.
Contents
The package contains either one DSS™ pedicle screw set,
one DSS™ rigid coupler or one DSS™ slotted coupler.
See package label for identification.
Description
Patents Pending in the US and other
territories
SYMBOLS
Manufacturer
REF
LOT
Catalog number
Lot number
Sterile using irradiation
Expiration date (Year-Month)
Do not reuse
Attention, see instructions for use
The DSS™ Stabilization System - Rigid consists of:
• DSS™ pedicle screw sets
• DSS™ rigid couplers The DSS™ Stabilization
System - Slotted consists of:
• DSS™ pedicle screw sets
• DSS™ slotted couplers All DSS™ implants are supplied
sterile and are available in various sizes.
The DSS™ pedicle screw set consists of 2 pedicle screws,
2 nuts, 2 spacers and 2 washers. The pedicle screws
are cannulated. The nuts, spacers and washers are used
to join the pedicle screws to the DSS™ rigid or slotted
coupler. The DSS™ pedicle screw set part number is on
the labeling. This part number is unique for each set and
does not match the part numbers marked on the individual
devices. For example, pedicle screw set “DPI5xxyy”
consists of:
• 2 x DAI06010, DSS™ nut
• 2 x DAI06020, DSS™ spacer
• 2 x DAI06030, DSS™ washer
• 2 x DAI4xxyy, DSS™ pedicle screw
“xxyy” is a variable field that is specific for each diameter
and length of pedicle screw.
The lot number of each device matches the lot number
of the set.
DSS™ Stabilization System - Rigid
The DSS™ rigid coupler consists of two interlocking
rods inside one another that are able to translate within a
limited range to meet the patient’s anatomy. The rods are
locked down with a set screw. The DSS™ rigid coupler
is the longitudinal member that increases the segmental
stiffness of the affected motion segment and restricts the
range of motion in flexion, extension, lateral bending,
translation and rotation to facilitate fusion.
The DSS™ Stabilization System - Rigid is for creating a
posterior spinal implant construct and is intended to be
used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion.
DSS™ Stabilization System - Slotted
The DSS™ slotted coupler is cylindrical, includes grooves
placed at intervals from the superior to the inferior end of
the device, and includes a pedicle screw interface at the
superior and inferior end of the device. The length of the
DSS™ slotted coupler is adjustable within a limited range
by rotating the pedicle screw interface (a 360º rotation
changes the length by 0.5 mm until the limit is reached).
The DSS™ Stabilization System - Slotted is intended to be
used with bone graft for fusion procedures.
The Rigid Coupler and Slotted Coupler are not intended to
be used together
Warnings and precautions
Warnings
The safety and effectiveness of pedicle screw spinal
systems have been established only for spinal conditions with significant mechanical instability or deformity
requiring fusion with instrumentation. These conditions
are significant mechanical instability or deformity of the
thoracic, lumbar, and sacral spine secondary to severe
spondylolisthesis (grades 3 and 4) of the L5–S1 vertebra,
degenerative spondylolisthesis with objective evidence
of neurologic impairment, fracture, dislocation, scoliosis,
kyphosis, spinal tumor, and failed previous fusion
(pseudarthrosis). The safety and effectiveness of the
DSS™ Stabilization System has not been established for
spinal indications beyond those stated in the Indications
section. Correct placement of the device is essential to
optimal performance. Use of the DSS™ Stabilization
System should only be undertaken after the surgeon has
become thoroughly knowledgeable about spinal anatomy
and biomechanics; has had experience with posterior
approach spinal surgeries; and has had hands-on training
in the use of this device.
The safety and effectiveness of this device has not been
established for the intended use of spinal stabilization
without fusion. The device is only intended to be used
when fusion with bone graft is being performed at all
instrumented levels.
The DSS™ rigid coupler is available in sizes ranging from
22–43 mm, and the DSS™ slotted coupler is available in
sizes ranging from 26–40 mm. Pre-operative planning is
required to ensure that this size range is appropriate for
the patient’s anatomy.
The Rigid Coupler and Slotted Coupler are not intended to
be used together
Precautions
All DSS™ implants are made from wrought titanium 6aluminum 4-vanadium alloy (ISO 5832-3).
Indications
Safety precautions
DSS™ Stabilization System - Rigid
The DSS™ Stabilization System - Rigid is intended as a
single-level system for noncervical pedicle fixation from
the T4 to S1 vertebrae in skeletally mature patients to help
provide immobilization and stabilization of spinal segments
as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic
origin with degeneration of the disc confirmed by history
and radiographic studies); spondylolisthesis; trauma (i.e.,
fracture or dislocation); spinal stenosis; curvatures (i.e.,
scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion. The DSS™ Stabilization
System - Rigid is intended to be used with autograft and/
or allograft.
DSS™ Stabilization System - Slotted
The DSS™ Stabilization System - Slotted is intended to
provide immobilization and stabilization of spinal segments
in skeletally mature patients as an adjunct to fusion in the
treatment of the following acute and chronic instabilities
or deformities of the thoracic, lumbar, and sacral spine:
degenerative spondylolisthesis with objective evidence of
neurologic impairment, kyphosis, and failed previous fusion
(pseudarthrosis).
In addition, the DSS™ Stabilization System - Slotted
Coupler is indicated for use in patients:
• Who are receiving fusions with autogenous graft only;
• Who are having the device fixed or attached to the
lumbar or sacral spine;
• Who are having the device removed after the
development of a solid fusion mass.
Note: The Rigid Coupler and Slotted Coupler are not
intended to be used together.
Contraindications
Do not use the DSS™ implant in cases of:
• Any medical, mental or surgical condition precluding the
potential benefit of spinal surgery or surgery in general
including conditions that have been shown to be safely
and predictably managed without the use of internal
fixation devices
• Acute or chronic systemic, spinal or localized infections
• Active, severe systemic and metabolic diseases
• Morbid obesity (BMI>40 or weight more than 100 lbs
over ideal body weight)
• Pregnancy
• Dependency on pharmaceutical drugs, drug abuse, or
alcoholism
• Lack of patient cooperation
• Foreign body sensitivity to the implant material
• Degenerative scoliosis greater than 25 degrees
• Any entity or condition that totally precludes the
possibility of fusion, i.e., cancer, kidney dialysis, or
significant osteopenia
• Severe osteoporosis as it may prevent adequate fixation of spinal anchors and thus preclude the use of
this or any other spinal instrumentation system
• Patients who may place undue stresses on the implant
during bony healing and may be at higher risk for
implant failure because of their occupation or lifestyle
• Soft tissue deficit not allowing wound closure
• Congenital abnormalities, tumors or other conditions
that would prevent secure component fixation that has
the potential to decrease the useful life of the device
• Inadequate pedicles or vertebral body geometry of the
thoracic, lumbar and sacral vertebrae
• Bony lumbar spinal stenosis
• Pars defect
• Clinically compromised vertebral bodies at affected
level due to current or past trauma
09/07
Adverse reactions may include:
• Nonunion, delayed union
• Implant bending or fracture
• Implant loosening
• Screw back-out, possibly leading to esophageal
erosion, implant loosening, and/or reoperation for
device removal.
• Clinical failure (i.e. pain or injury) due to bending,
loosening, wear and tear, fracture of implant, loss of
fixation, dislocation and/or migration
• Pain, discomfort and/or abnormal sensations due to the
presence of the implant
• Degenerative changes or instability in segments
adjacent to fused vertebral levels
• Decrease in bone density due to stress shielding
• Primary and/or secondary infections
• Metal sensitivity or allergic reactions to implant material
• Neurological injury due to surgical trauma or device
presence. Neurological difficulties including radicular
pain, tethering of nerves in scar tissue, muscle
weakness, and paresthesia.
• Vertebrae fracture or fracture of bony structures
• Injury to vessels, nerves and organs. Vascular damage
could result in catastrophic or fatal bleeding. Malpositioned implants adjacent to large arteries or veins could
erode these vessels and cause catastrophic bleeding.
• Bursitis
• Hematoma and/or impaired wound healing;
hemorrhage
• Venous thrombosis, lung embolism, and cardiac arrest
• Esophageal perforation, erosion or irritation
• Damage to lymphatic vessels and/or lymphatic fluid
exudation
• Dural tears during surgery could result in the need for
further surgery for dural repair, a chronic CSF leak or
fistula, and possible meningitis
• Spinal cord impingement or damage
• Paralysis
•Death
Only experienced spinal surgeons should perform the
implantation of pedicle screw spinal systems with specific
training in the use of the DSS™ Stabilization System Rigid and DSS™ Stabilization System - Slotted. This is
due to the technically demanding procedure presenting
a risk of serious injury to the patient. This system should
only be used with instrumentation specifically designed
for this system.
The DSS™ Stabilization System - Rigid and DSS™
Stabilization System - Slotted are intended to be used with
bone graft which is required to provide additional spinal
support and facilitate fusion. A successful result is not
always achieved in every surgical case.
Material
LBL 0554
Adverse reactions
• Prior to use, thoroughly read these instructions for use
and become familiar with the surgical technique.
• Keep the instructions for use accessible to all staff.
The operating surgeon must have a thorough command of
both the hands-on and conceptual aspects of the established operating techniques. Proper surgical performance
of the implantation is the responsibility of the operating
surgeon.
• The manufacturer is not responsible for any complications arising from incorrect diagnosis, choice of
incorrect implant, incorrect operating techniques, the
limitations of treatment methods or inadequate asepsis.
• Under no circumstances may modular implant
components from different suppliers be combined.
• Each patient’s record shall document the implant used
(name, article number, lot number).
• During the postoperative phase, in addition to mobility
and muscle training, it is of particular importance that
the physician keeps the patient well informed about
post-surgical behavioral requirements.
• Damage to the weight-bearing structures can give rise to
loosening, dislocation and migration, as well as other
complications. To ensure the earliest possible detection
of such catalysts of implant dysfunction, the implant
must be checked periodically post operative using appropriate techniques.
• Never reuse an implant. Although the implant may appear undamaged, previous stresses may have created
non-visible damage that could result in implant failure.
• Never use implants if the packaging is damaged. An
implant with damaged packaging might be damaged
itself and thus may not be used.
• Never use implants that are past their expiration date.
• Do not resterilize implants.
The safety and effectiveness of this device has not been
established in patients with the following conditions:
• Prior fusion surgery at any vertebral level
• Facet joint disease or degeneration
• Back or leg pain of unknown etiology
• Paget’s disease, osteomalacia, or other metabolic bone
disease
• Morbid obesity (BMI >40 or weight more than 100 lbs
over ideal body weight)
• Pregnancy
• Taking medications known to potentially interfere with
bone/soft tissue healing (e.g., steroids)
• Rheumatoid arthritis or other autoimmune disease
• Systemic disease including AIDS, HIV, Hepatitis
• Active malignancy.
Storage, inspection and sterilization
The DSS™ implants are packed in protective packaging
that is labeled according to its contents. The implants are
sterilized with gamma sterilization (25 kGy minimum).
• Always store the implant in the original protective
packaging.
• Do not remove the implant from the packaging until
immediately before use.
• Store the implant in a dry and dust-free place (standard
hospital environment).
Disinfection / cleaning
The DSS™ implants are not designed to be disinfected or
cleaned by the user.
Resterilization
The DSS™ implants are not designed to be resterilized
by the user.
Procedure
The DSS™ implants must be implanted only with the applicable DSS™ instruments. The DSS™ instruments are
available from the manufacturer.
Preoperative
The operating surgeon draws up an operation plan
specifying and documenting the following:
• Implant components and their dimensions.
• Proper position of the implant components.
• Determination of intraoperative orientation points.
The following conditions must be fulfilled prior to
application:
• All required implant component(s) are readily available.
• Highly aseptic operating conditions are present.
• All requisite implantation instruments must be available
and in working order.
WARNING:
Never use or process damaged or defective instruments.
Contact your local representative or dealer for repair or
replacement.
WARNING:
The use of an instrument for tasks other than those for
which they are intended may result in damaged / broken
instruments or patient injury.
• The operating surgeon and operating room team must
be thoroughly familiar with the operating technique,
as well as the range of implants and instruments to be
applied. Complete information on these subjects must
be readily available at the workplace.
• The operating surgeon must be especially trained in
spinal surgery, biomechanical principles of the spine
and the relevant operating techniques. The operating
procedure must be explained to the patient, and the
patient’s understanding of the following information
must be documented:
• The patient is aware of the risks associated with neurosurgery, general surgery, orthopedic surgery and with
general anesthesia.
• The patient has been informed about the advantages
and disadvantages of the implant procedure and about
possible alternative treatments.
• The implant can fail due to excessive load, wear and
tear, or infection.
• The service life of the implant is determined by body
weight and physical activity. The implant must not
be subjected to overload through extreme strain, or
through work-related or athletic activities.
• Corrective surgery may be necessary if the implant
fails.
• The patient must have their physician carry out followup examinations of the implant at regular intervals.
Intraoperative
DSS™ Stabilization System - Rigid & DSS™ Stabilization
System - Slotted
Prior to use, verify the integrity of the sterile packaging
and check the product expiration date.
WARNING:
Never use implants if the packaging is damaged. Never
use implants that are past their expiration date.
Prepare the surgical site for implant introduction. Numerous instruments (e.g., trocar, awl, pedicle finder, reamer,
tap and pedicle probe) are provided to prepare the
pedicles prior to screw insertion. Introduce the pedicle
screws into the pedicles of the affected motion segment
using the pedicle screw inserter (note: the pedicle screws
are cannulated and may be used with standard 1.6 mm
Kwires). Attach the pedicle screw extension rods to the
pedicle screws (after removing K-wires, if applicable).
Measure the distance between the pedicle screws using
the caliper set, and select the applicable size coupler
based on the measured distance.
DSS™ Stabilization System - Rigid
Apply the rigid coupler to the pedicle screws. Add a spacer
using the spacer inserter, then a washer and then a nut
using the nut driver to each pedicle screw. Use a distraction and/ or compression instrument to achieve sagittal
alignment. Once aligned, use the hex driver to “lock” the
rigid coupler. Fix the rigid coupler to the pedicle screws
by tightening the nuts. A counter torque instrument shall
be utilized to avoid movement of the pedicle screws. If
desired, the tightening of the nuts may be done prior to
“locking” the rigid coupler. Again, the proper tightening
torque is reached when the upper half of the nut breaks
off. Bone graft shall be used to facilitate fusion.
DSS™ Stabilization System - Slotted
Adjust the slotted coupler to the measured distance using
the coupler length adjuster. Do not apply excessive force
when adjusting the slotted coupler length. The slotted
coupler has built in stops that limit the minimum and
maximum adjustment range.
For single level stabilization with the slotted coupler, apply
the slotted coupler to the pedicle screws in the orientation
as indicated on the implant (the cranial direction is marked
with UP and an arrow on the slotted coupler). The coupler
pusher may be used to firmly seat the slotted coupler
onto the pedicle screws. Add a spacer using the spacer
inserter, then a washer and then a nut using the nut driver
to each pedicle screw (note: alternative configurations
may be used by the surgeon in order to optimize the fit
to the anatomy such as screw, washer, spacer, slotted
coupler, nut). Fix the slotted coupler to the pedicle screws
by tightening the nuts utilizing a counter torque instrument
to avoid bending of the slotted coupler and movement of
the pedicle screws during tightening. If desired, remove
the extension rods with the extension rod remover prior
to applying the counter torque instrument. The proper
tightening torque is reached when the upper half of the nut
breaks off. The slots of the slotted coupler shall remain
parallel during tightening (note: if the slots of the slotted
coupler are not parallel, correct the coupler position using
a counter torque instrument). Remove all instruments.
For multi-level cases, only the pedicle screws at both
ends of the instrumentation receive a washer. The screws
in between receive a first coupler, a spacer, a second
coupler and the nut. Any additional washers contained
in the blister package shall be disposed. Other than this,
the proper technique is applicable as described above for
device placement.
Bone graft shall be used to facilitate fusion.
Postoperative
• Reiterate preoperative instructions to the patient.
• Ensure that the patient is aware of physical activity
restrictions and possible adverse reactions.
Revision surgery / implant removal
The DSS™ implants are intended for permanent
implantation and are not intended for removal. However,
removal may be advisable in the following situations:
• Implant breakage
• Pain due to the implant
• Infection
• After the development of a solid fusion mass in patients
where this is so desired
Warranty
All warranty rights are lost if repairs or modifications
are carried out by an unauthorized service center. The
manufacturer does not take responsibility for any effects
on safety, reliability or performance of the product if the
product is not used in conformity with the instructions for
use. Technical alterations reserved.
For further information
Please contact Paradigm Spine or your authorized
representative if further information on this product
is needed.
Important note
This ‘Instructions for Use’ is complete on the date of
printing. In the future, additional components of the DSS™
Stabilization System - Rigid and/or DSS™ Stabilization
System - Slotted may be added. If using a new component
of the DSS™ Stabilization System that is not described in
this document, refer to the ‘Instructions for Use’ packaged
with that device.