Medtronic MS025 Instructions for Use
IMPORTANT MEDICAL INFORMATION
PASSMED® spinal system
PASS LP® spinal system
MEDICREA® INTERNATIONALS.A.
US – VALID ONLY FOR THE USA
Manufactured by :
MEDICREA® INTERNATIONA LS.A. (Customer service department)
5389 Route de St rasbourg – Vancia – 69140 Rill ieux la Pape – France
Phone: +33 (0)4 72 01 87 87. Fax: +33 (0)4 72 01 87 88
E-mail: customerservice@medicrea.com
CAUTION: USA Federal law restric ts this device to sale by or on
the orde r of physician.
SUBJECT
PASSMED® and PASS LP® implants are medical devices designed to
contribute to correction and surgical stabilization of the thoracic, lumbar
and sacral spine only. These devices should not be used in the cervical
region. These implants are designed to stabilize the spine during normal
development of solid bony consolidation which takes about 18 months.
After this period the presence of the device is no longer strictly necessary
and removal of the material used can be envisaged.
DESCRIPTION
The internal xation devices are composed of screws, hooks, rods, plates,
cross links, connection and locking devices.
The range of dierent sizes and shapes of the implants allows the surgeon
to adapt to the pathology and morphology of each of his patients.
The implants are manufactured in titanium alloy Ti-6Al-4V ELI
conforming to ISO 5832-3 specications and ASTM F136 specications,
with the exception of the rods intended for in situ bending which are
manufactured in non-alloyed titanium (CP titanium) conforming to
ISO5832-2 specications and ASTM F67 specications and the CoCr rods
which are manufactured in cobaltchrome alloy Co-Cr28Mo6 conforming
to ISO 5832-12 specications and ASTM F1537 specications. Under no
circumstances are the implants reusable.
INDICATIONS, CONTRAINDICATIONS AND POTENTIAL UNDESIRABLE EFFECTS
Indications:
The PASSMED® and PASS LP® Spinal Systems include a pedicle system
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 thoracic, lumbar,
and sacral spine:
- Fractures.
- Dislocation.
- Failed previous fusion (Pseudarthrosis).
- Spinal stenosis.
- Degenerative spondylolisthesis with objective evidence of neurological
impairment.
- Spinal deformations such as scoliosis or kyphosis.
- Loss of stability due to tumors.
The PASSMED® and PASSLP® Spinal Systems are also indicated for pedicle
screw xation for the treatment of severe spondylolisthesis (Grades 3 and
4) of the L5–S1 vertebra in skeletally mature patients receiving fusion by
autogenous bone graft having implants attached to the lumbar and sacral
spine (L3 to sacrum) with removal of the implants after the attainment of
a solid fusion.
The PASSMED® and PASSLP® also include hooks and rods and sacral/ iliac
screws indicated for degenerative disc disease (ddd) dened as back
pain of discogenic origin with degeneration of the disc conrmed by
history and radiographic studies, spondylolisthesis, trauma (i.e., fracture
or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudarthrosis and failed previous
fusion.
CAUTION: to be used on or according to the prescription of a
medical practitioner
Implantation of this device should only be performed by a surgeon who is
familiar with the device, its intended use, the ancillary instruments, and
understands all aspects of the surgical procedure.
Contraindications:
The non-exhaustive list of contraindications includes:
1. Active infection at the operative site.
2. Local inammation.
3. Fever or leukocytosis.
4. Pathologic obesity.
5. Pregnancy.
6. Mental illness.
7. Any medical or surgical condition which would compromise the success
of the procedure (e.g. malignant tumors or severe developmental
anomalies, elevation of ESR that is not attributable to other
pathologies, increase or decrease in white blood cell count).
8. Rapidly developing joint disease, bone resorption, osteopenia, and/ or
osteoporosis. Osteoporosis is a relative contraindication because it
may result in insucient correction and compromise stability of the
mechanical xation.
9. Allergies and intolerance (suspected or known) to metals.
10. Any condition that does not require bone grafting or bone fusion.
11. Anomaly or fracture of vertebrae.
12. Any situation that requires the combination of dierent metals.
13. Any patient with poor tissue coverage at the operative site.
14. All cases which do not come under the above mentioned «Indications».
15. Patients who are unwilling to follow postoperative instructions.
16. Patients in whom use of the implant may interfere with anatomical
structures or a physiological function.
Contraindications are similar to those applying to other spinal implants.
This spinal implant is not
designed, intended or sold for uses other than those previously mentioned.
Possible undesirable eects and warnings:
In addition to the risks associated with surgery of the spine without
instrumentation, a number of
possible undesirable eects may occur with instrumented surgery
(including but not limited to):
1. Detachment, deformation, mobilization, slipping, breakage of one or
all of the components.
2. Pain due to the surgery, the fracture, deformation and or migration of
an implant.
3. Fracture of the pedicle during insertion of a pedic ular screw.
4. Fracture of vertebrae.
5. Allergic reaction to the implanted materials and the presence of microparticles around the implants (metallosis).
6. Cutaneous problems with the components in areas where the tissue
cover is insucient accompanied by pain and abnormal sensations due
to the volume of the device.
7. Bursitis.
8. Postoperative loss of correction and/or reduction of the spine, partial or
total loss of the corrections achieved.
9. Deep or super cial infection with an inammatory reaction.
10. Pseudarthrosis.
11. Neural damage or neural decit due to surgical trauma.
12. Leakage of cerebrospinal uid.
13. Gastrointestinal disorders, urinary tract disturbances, and/or
reproductive disorders including sterility, impotence.
14. Excessive intraoperative bleeding and/or hematomas.
15. Growth arrest in fused spinal segments.
16. Vascular disorders (thrombosis) and/or pulmonary embolism.
17. Patient’s inability to resume normal activities of daily living.
18. Dural tear.
19. Disease (deterioration) of the adjacent segments to the assembly
20. Death.
NOTE: Some of the above adverse eects may necessitate surgical revision.
IMPLANT INSERTION
Implants are inserted using instruments specially made for this purpose.
It is important that you refer to the surgical protocol and the operating
instructions for the instruments. Dierent instrumentation should not
be used, unless this is specically recommended in another MEDICREA®
INTERNATIONAL S.A. document as the combination with other
instrumentation may be incompatible and cannot be guaranteed.
NEVER REUSE AN IMPLANT. The consecutive use of an implant creates
a risk of contamination and loss of integrity of its mechanical properties.
PACKAGING
The packaging of each component should be intact on reception. All legally
required information for this type of implant is indicated on the label
axed to each package.
If loaner kits or consignment sets are used, devices delivered as non-sterile
should be carefully checked before their use for completeness and that
there is no sign of damage. Before sterilization by autoclaving, remove all
packaging material from devices delivered as non-sterile.
It is essential to clean and immediately resterilize any implant not
used or instrument that has been in the operating theatre. This must
be carried out before handling, or return of the products to MEDICREA®
INTERNATIONALS.A..
All devices the packing and/or packaging of which is damaged, must not
be used and must be returned to MEDICREA® INTERNATIONALS.A..
STORAGE AND HANDLING
No special storage conditions are required.
INSPECTION OF STERILE IMPLANTS
When MEDICREA® INTERNATIONALS.A. implants have been sterilized by
gamma radiation you should check that the dot (sterility indicator) on
the outer packaging is red. Do not use the implant if the dot is not red.
You should also check the sterility expiry date marked on the packaging.
MEDICREA® INTERNATIONALS.A. accepts no responsibility if implants are
used that have passed their expiry date. If the packaging is damaged or
torn, the implant must not be resterilized but should be returned to
MEDICREA® INTERNATIONALS.A..
WARNING: Do not resterilize an implant that has already been
sterilized.
DECONTAMINATION, CLEANING AND STERILIZATION OF IMPLANTS
DELIVERED AS NONSTERILE
It is imperative that all implantable devices which have been removed
from their packaging, including those previously supplied and/or loaned
and those which have been in the operating theatre, be thoroughly
decontaminated and cleaned before being sterilized.
Decontamination and Cleaning
Decontamination and cleaning must be carried out either manually or
mechanically according to the method or methods validated by the care
unit. The decontamination and cleaning equipment should be checked and
validated by the care unit.
A broad-spectrum bactericidal and antifungal product should be used for
washing before sterilization. Oxidation tests should be performed before
using any cleaning product.
Aggressive cleaning products such as strong mineral acids (sulfuric,
nitricetc.), bleach, or formol which will damage the devices, in particular
the instruments, should not be used. Abrasive products or instruments
(sponges or brushes) should also not be used.
WARNING: The use of caustic soda is strictly prohibited.
Inspecting the device
After decontamination and cleaning, the care unit should inspect the
devices. Any device showing signs of damage or scratches on its surface
should not be used.
Sterilization
After decontamination and washing the implants are then sterilized by
steam autoclaving, following the care unit’s internally validated procedure
which should take into account the type of equipment and the type and
number of products present in the autoclave.
If sterilization cases with paper lters are used, the integrity of the lters
should be checked before sterilization.
MEDICREA® INTERNATIONAL S.A. has validated the following cycles
described in the table below:
Method Cycle
Steam
Pre-
vaccum
Temperature
Duration of
treatment
134°C (274°F) 18 minutes
132°C / 270°F 4 minutes
Drying
Time
20-30
minutes
The 134°C pre-vaccum sterilization cycle is not considered by the Food
and Drug Administration to be a standard sterilization cycle. It is the
end user’s responsibility to use only sterilizers and accessories (such as
sterilization wraps, sterilization pouches, chemical indicators, biological
indicators, and sterilization cassettes) that have been cleared by the Food
and Drug Administration for the selected sterilization cycle specications
(18 minutes and 134°C). If contamination by unconventional transmissible
agents is suspected, MEDICREA® INTERNATIONALS.A. recommends to use
the cycle with 134°C for 18 minutes. The use of any other sterilization
method is solely the responsibility of the user and releases MEDICREA®
INTERNATIONALS.A. from any responsibilit y.
WARNINGS AND PRECAUTIONS
WARNING: The safety and eectiveness of pedicle screw spinal systems
have been established only for spinal conditions with signicant
mechanical instability or deformity requiring fusion with instrumentation.
These conditions are signicant 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 eectiveness of these devices for any
other conditions are unknown.
PRECAUTION: The implantation of pedicle screw spinal systems
should be performed only by experienced spinal surgeons with specific
training in the use of this pedicle screw spinal system because this is
a technically demanding procedure presenting a risk of serious injury
to the patient.
The surgeon must be thoroughly knowledgeable not only in the medical
and surgical aspects of the implant, but must also be aware of the
mechanical and metallurgical limitations of metallic surgical implants.
Postoperative care is extremely important. The patient must be instructed
in the limitations of the metallic implant and be warned regarding weight
bearing and body stresses on the appliance prior to rm bone healing.
The patient should be warned that non compliance with postoperative
instructions could lead to failure of the implant and possible need
thereafter for additional surgery to remove the device.
PASSMED® and PASS LP® components should not be used together;
PASSMED® and PASS LP® spinal systems should not be used with
components of any other system or manufacturer.
MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion
damage and several of these occur on metals surgically implanted in
humans. General or uniform corrosion is present on all implanted metals
and alloys. The rate of corrosive attack on metal implant devices is usually
very low due to the presence of passive surface lms. Dissimilar metals
in contact, such as titanium and stainless steel, accelerate the corrosion
process of stainless steel and more rapid attack occurs. The presence of
corrosion often accelerates fatigue fracture of implants. The amount of
metal compounds released into the body system will also increase
MRI SAFETY INFORMATION
As the devices are made from metal (Titanium Alloy, CoCr Alloy or
Tantalum), interferences such as artifacts may be possible in MRI scans.
The PASSMED® and PASS LP® have not been evaluated for safety and
compatibility in the MR environment. They have not been tested for
heating, migration, or image artifact in the MR environment. The safety of
the PASSMED® and PASSLP® in the MR environment is unknown. Scanning
a patient who has this device may result in patient injury.
OTHER PREOPERATIVE, INTRAOPERATIVE AND POSTOPERATIVE WARNINGS
Implant selection:
The devices must always be checked before use. Those with signs of
damage or scratches on their surface should not be used. The choice of
shape and size of the implant suited to each patient is essential for the
success of the procedure. Once implanted, metal implants are subjected
to repeated stress, and their strength is limited by the adaptation
of their geometry to the size and shape of the human bones. Proper
patient selection criteria, correct implant positioning, and appropriate
postoperative care are therefore essential to minimize stress loading of the
implant.
If this is not done and excessive loading is placed on the internal
xation device, this may increase the attendant risks of fracture and/or
deformation of the implant and may eventually lead to loosening before
bone union is achieved. This in turn, may cause damage or necessitate
premature removal of the implant. Therefore:
- 4.5 mm diameter pedicle screws should only be used in the lower thoracic
spine (T7 to T12), and should not be used in overweight patients.
- 5 mm diameter pedicle screw should be used in the lower thoracic or
upper lumbar spine (T7 to L3).
- 5.5 mm diameter pedicle screws must be reserved for the upper lumbar
spine (L1, L2 and L3).
- 6.5 mm diameter pedicle screws must be reserved for the lower lumbar
spine (L4 and L5).
- 7.2 mm or larger diameter pedicle screws must be reserved for the
sacrum.
- Screws with length from 60mm to 100mm must be reserved for the iliac
wing.
- 6.5 mm or larger diameter sacral screws must be reserved for the xation
of sacral plates on the sacrum.
The benets of spinal fusion using pedicle screw xation systems have not
been fully established in patients with a stable spinal column.
Similarly, the use of the dierent hooks must comply with the
instructions for use contained in the surgical protocol provided by
MEDICREA® INTERNATIONALS.A.. Each hook has been specially designed
for placing in a specic location in the vertebral column (described
in the surgical technique). Incorrect use in locations other than
those recommended by MEDICREA® INTERNATIONAL S.A. cannot be
guaranteed.
Furthermore, MEDICREA® INTERNATIONAL S.A. recommends the use of
anchoring claws consisting of two hooks guaranteeing maximum stability.
Hooks used singly, cannot therefore provide the same guarantee of xation
as a claw (consisting of two opposing hooks).
Other precautions:
For traceability reasons, the rods should not be cut.
Preoperative precautions:
1. Only patients meeting the criteria described in the «Indications» should
be selected.
2. Patients meeting the criteria described in the «Contraindications» above
should not be selected.
3. Use extreme care in handling and storing the implants. Implants should
not be scratched or
4. damaged. Implants and instruments should be protected during
storage particularly from corrosive environments.
5. Further information regarding the use of this system can be provided
upon request.
6. As implantation is concerned, the surgeon should be perfectly familiar
with all the components of the device before use and should personally
handle them to check that all the necessary implants and instruments
are available before performing the procedure.
7. In particular, the surgeon should determine the type of construction
that he will use and ensure that an adequate implant range is available.
8. Unless the components are supplied sterile, they should all be cleaned
and sterilized before use. Extra sterile components should be available
in case an unexpected need arises.
MEDICREA® INTERNATIONALS.A. instrument selection:
Selecting the appropriate instrumentation is critical to the success of
the procedure. it is essential to use the set of instruments specic to
MEDICREA® INTERNATIONAL S.A. implantable devices to carry out the
surgical procedure.
Intraoperative precautions:
1. Selection of the appropriate instrumentation is critical to the success of
the procedure.
2. MEDICREA® INTERNATIONALS.A. surgical protocol instructions for the
implantation of the internal xation device should be followed strictly.
Breaking, slipping or incorrect use of the instruments or implants for the
system may injure the patient or the operating personnel.
3. Each MEDICREA® INTERNATIONALS.A. internal xation device should be
used with the instruments specially designed for the device. It should
not be used with dierent instrumentation unless this is specically
recommended in another MEDICREA® INTERNATIONALS.A. document as
the combination with other instrumentation may be incompatible and
cannot be guaranteed.
4. If a problem occurs during the procedure or while handling the
implants, carefully check that the surfaces of the implant have not been
scratched or scored.
5. CAUTION: Throughout the procedure, the surgeon must use extreme
care in dealing with the spinal cord and nerve roots. This warning is
particularly important during the insertion of bone screws which must
be of the correct dimensions (length, diameter) to prevent possible
damage to nerves, a hemorrhage or avulsion. Any nerve injury may
result in a neural decit.
6. Repeated or excessive bending of the rods should be avoided as much
as possible. Do not reverse the bend of an already bent rod at the same
point.
7. In order to achieve arthrodesis or consolidation, the xation systems
should be used in association with a bone graft (ideally, an autologous
graft).
Postoperative precautions:
The postoperative instructions and warnings given by physicians to
the patients and the patient’s willingness to heed them are extremely
important.
1. The patient should be instructed in detail on the use and limitations of
the device. The surgeon should inform the patient about limiting eort
during the postoperative period. Overloading could cause deformation,
loosening or breakage of the temporary internal xation device.
2. For the surgery to have every chance of succeeding, the patient
should be aware of the risks and given advice so that he restricts
physical activities, particularly those involving torsion and lifting, and
participation in sports. The patient should be advised against excessive
alcohol or tobacco consumption during consolidation of the bone graft.
3. Absence of bone fusion will result in repeated excessive stresses on
the internal xation devices. Through fatigue, these stresses may
nally cause deformation, loosening or breakage of the device. It is
important to immobilize the area of fusion and conrm by radiological
examination that fusion is occurring. In the case of persistent nonunion, or if the components begin to loosen, deform and/or break, the
device should be revised and/or removed without delay, before any
serious damage occurs.
4. Rigid bracing is not systematically required. The decision to brace or not
is left to the surgeon’s discretion and depends on various criteria (the
patient’s age, weight, physical activity, bone quality etc.).
5. MEDICREA® INTERNATIONALS.A. internal xation systems have been
designed to provide stabilization of the operative site during normal
bone consolidation. After the occurrence of consolidation, the device
serves no further useful function. After bone consolidation the removal
of the implanted device can be envisaged; this is the surgeon’s decision.
6. Once removed, the implant should be treated so as to prevent its reuse
in another procedure.
ADDITIONAL INFORMATION
For any further information about this device or to request a surgical
technique, please contact MEDICREA® INTERNATIONAL S.A. Customer
Service Department or the distributor.
CLAIMS CONCERNING THE PRODUCT
Any health care professional (e.g.: customer or user of this system)
who wishes to put in a claim or is not fully satised with the
product quality, identication, durability, reliability, safety, ecacy
and/ or performance, should contact the distributor or MEDICREA®
INTERNATIONAL S.A.. Furthermore, malfunction (i.e. failure to provide
the intended performance or to operate satisfactorily) or suspected
malfunction should be immediately reported to the distributor or
MEDICREA® INTERNATIONAL S.A.. Any serious adverse eect or death
that might have been provoked by incorrect functioning of a MEDICREA®
INTERNATIONALS.A. device should be reported to the distributor or to
MEDICREA® INTERNATIONALS.A. as soon as possible by telephone, fax
or in writing. For any claim, please mention name, catalogue number,
and manufacturing lot number of the component(s), as well as your
full name and address and the nature of your claim. Also, please specify
whether a written report is requested from the distributor or MEDICREA®
INTERNATIONALS.A..
PATIENT INFORMATION
MEDICREA® INTERNATIONAL S.A. spinal osteosynthesis implants are
designed to contribute to correction and surgical stabilization of the
thoracic, lumbar and sacral spine only. This device is not to be used in the
cervical region. These implants are designed to stabilize the spine during
the normal development of solid bony consolidation which takes about 18
months.
The specic indications for the implants are described in the paragraph
«INDICATIONS, CONTRAINDICATIONS AND POTENTIAL UNDESIRABLE
EFFECTS».
It has been shown that these implants are an appreciable help to doctors
treating the conditions mentioned above. However, this internal xation
does not have the properties of living bone. Living bone repairs itself, is
exible and sometimes may break and/or deteriorate. The anatomy of the
human body limits the dimensions of any articial consolidation device
used in surgery. This geometrical limitation increases the possibilities of
mechanical complications such as the development of play in the tting,
deformation, or breaking of the device. These complications may lead to
an additional surgical operation to remove or possibly replace the device.
It is therefore essential that you follow your physician’s instructions very
carefully regarding postoperative behavior: Limit your activities to those
recommended by your surgeon. On the recommendation of your doctor
use immobilizing aids or other devices to partly or totally support your
weight. By following these instructions you will increase your chances
for a successful outcome, and will reduce the potential for injuries and/or
another operation.
REMOVAL AND DISPOSAL OF MEDICAL DEVICES
The retrieval and handling of surgical implants will be carried out in
compliance with the recommendations of one of the following two norms:
FD S94-030 «Surgical implants - Guide for the retrieval, handling and
analysis of surgical implants» or ISO 12891-1 « Retrieval and analysis of
surgical implants. Part 1: retrieval and handling.»
The disposal of explanted medical devices must be carried out in
compliance with the legislation in force in the country of use. In France,
disposal will be carried out in accordance with decree n° 97- 1048 dated
06 November 1997 relating to the disposal of healthcare waste with an
infectious or similar risk and of anatomical specimens.
No particular measures are required for the disposal of unused medical
devices.
WARNING
The manufacturer’s liability is limited solely to the applications and uses
specied in this document.
US INSTRUCTIONS FOR USE
VALID ONLY FOR THE USA
REFERENCE : C02D01005 - Version 03
Last revised update: 04/2019
Symbols
Do not reuse
Do not resterilize
Caution
Consult instructions for use
Sterilized using irradiation
Non sterile
Do not use if the packaging is damaged
Catalog number
Batch code
QTY
Quantity
Dimension
DIM
Use by
Manufacturer
Date of manufacture
Caution : Federal (USA) law restricts the sale and/or the
Rx Only
use of this device to or on the order of a physician
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