Medtronic B19114535 Instructions for Use
IMPORTANT MEDICAL INFORMATION
PASS® XS Spinal System
MEDICREA® INTERNATIONALS.A.
EN / USA
Manufactured by :
MEDICREA® INTERNATIONA LS.A. (Customer service department)
5389 Route de Strasbourg – Vancia – 69140 Rillieux 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:
Caution: Federal (USA) law restricts the sale and/or the use of this
device to or on the order of a physician.
INTENDED USE
PASS® XS implants are 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 12 months.
DESCRIPTION
The internal xation devices are composed of screws, rods, crosslinks,
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 and cobalt
chrome alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
As any orthopaedic implant, these implants must not be reused.
For a complete guide of the system, please refer to surgical technique
manual for specic instructions.
INDICATIONS, CONTRAINDICATIONS AND POTENTIAL ADVERSE EVENTS
INDICATIONS
The PASS® XS Spinal System is a pedicle screw xation system intended for
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 disc disease (dened as discogenic back pain with
degeneration of the disc conrmed by history and radiographic studies),
spondylolisthesis, trauma (e.g., fracture or dislocation), deformity or
curvature (e.g., scoliosis, kyphosis, and/or lordosis), tumor, spinal stenosis,
pseudarthrosis, or failed previous fusion.
When used for posterior non-cervical pedicle screw xation in pediatric
patients, the PASS® XS Spinal System implants are indicated as an adjunct
to fusion to treat adolescent idiopathic scoliosis. The PASS® XS Spinal
System is intended to be used with autograft and/or allograft. Pediatric
pedicle screw xation is limited to a posterior approach
CONTRAINDICATIONS
The non-exhaustive list of contraindications includes:
1. Any signs of local or systemic infection or inammation.
2. Pathologic obesity.
3. Pregnancy.
4. Allergies and intolerance (suspected or known) to metals.
5. Any condition that does not require bone grafting or bone fusion.
6. Any patient with poor tissue coverage at the operative site.
7. All cases which do not come under the above mentioned “INDICATIONS”.
8. Patients who are unwilling to follow postoperative instructions.
9. Patients in whom use of the implant may interfere with anatomical
structures or a physiological function.
Contraindications are identical to those applying to other similar devices.
This system is not designed, intended or sold for uses other than those
previously mentioned.
POTENTIAL ADVERSE EFFECTS
In addition to the risks associated with surgery of the spine without
instrumentation, a number of possible adverse events may occur with
instrumented surgery, including but not limited to:
1. Detachment, deformation, mobilization, slipping, breakage of one or all
of the components.
2. 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.
3. Postoperative loss of correction and/or reduction of the spine, partial or
total loss of the corrections achieved.
4. Deep or supercial infection with an inammatory reaction.
5. Neurological complication.
6. Vascular disorders (thrombosis) and/or pulmonary embolism.
7. Pain due to the surgery, the fracture, deformation and or migration of
an implant.
8. Fracture of the pedicle during insertion of a pedicle screw.
9. Allergic reaction to the implanted materials and the presence of microparticles around the implants (metallosis).
10. Pseudarthrosis.
11. Excessive intraoperative bleeding and/or hematomas.
12. Patient’s inability to resume normal activities of daily living.
13. Disease (deterioration) of the adjacent segments to the assembly.
14. Death.
NOTE: Some of the above adverse events may necessitate surgical revision.
IMPLANT INSERTION
Implants are inserted using dedicated instruments. It is important to refer
to the surgical protocol and the operating instructions for the instruments.
Implants should not be used with non-associated instruments, unless
this is specically recommended in a MEDICREA® INTERNATIONAL S.A.
document as the combination may be incompatible and cannot be
guaranteed. MEDICREA® INTERNATIONALS.A. accepts no responsibility if
non-associated instruments are used.
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 at reception. All legally
required information for this type of implant is indicated on the label
axed to each package.
If a loaner kit or a consignment set is used, devices delivered as non-sterile
should be carefully checked before their use to ensure that there is nothing
missing and no sign of damage. Before sterilization by autoclaving,
all packaging material from devices delivered as non-sterile should be
removed.
Any unused implant or any instrument that has been in the operating
theatre must imperatively be cleaned and then resterilized before
handling, or return to MEDICREA® INTERNATIONALS.A..
Any damaged product or any product which packaging is
damaged must not be used and must be returned to MEDICREA®
INTERNATIONALS.A..
STORAGE AND HANDLING
No special storage conditions are required.
DECONTAMINATION, CLEANING AND STERILIZATION OF IMPLANTS
DELIVERED AS NON-STERILE
It is imperative that all implantable devices which have been removed
from their packaging, be thoroughly decontaminated and cleaned before
being sterilized.
DECONTAMINATION AND CLEANING
Decontamination and cleaning must be carried out 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,
nitric etc.), 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 carry out a visual
inspection the devices. Any device showing signs of damage or scratches
on its surface should not be used.
STERILIZATION
After decontamination, washing and inspection, the implants are 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:
134°C -
274°F
132°C -
270°F
134°C -
274°F
Duration of
treatment
18 minutes
4 minutes
3 minutes
Drying
time
20-30
minutes
Standard
cycle
Europe
U.S.A.
United
Kingdom
Method Cycle
Steam
Pre-
vacuum
Temperature
To prevent transmission of the Creutzfeldt-Jakob disease and other
unconventional transmissible agents, the sterilization cycle with 134°C
for 18 minutes is recommended by MEDICREA® INTERNATIONALS.A., but
this cycle is not considered by the Food and Drug Administration to be a
standard sterilization cycle. Sterilizers and accessories such as sterilization
wraps, sterilization pouches, chemical indicators, biological indicators, and
sterilization cassettes must only be used if they have been FDA cleared for
the selected sterilization cycle.
The use of any other sterilization method, equipment or accessories is solely
the responsibility of the user and releases MEDICREA® INTERNATIONALS.A.
from any responsibility.
MRI SAFETY INFORMATION
The PASS® XS implants have not been tested in the magnetic resonance
environment (MRI), nevertheless a review of the literature makes it
possible to determine the absence of risks of heating, migration and
distortion under a 1.5T magnetic eld routinely used. However, risks of
minor artefacts for the patient remain possible, limiting clinical follow-up
to instrumented disc levels. The radiologist performing the imaging should
be informed of the presence of the implants and make the necessary
adjustments to limit these artifacts. X-rays or scans are still possible
without risk to the patient.
WARNINGS AND PRECAUTIONS
Every surgical procedure involves a risk of failure, particularly in spine
surgeries. Any concurrent condition may adversely aect the outcome, in
particular when patient’s general state of health is deteriorated. This device
should be associated with bone graft, and be used only when bone healing
is possible. No spinal implant can be expected to withstand normal loading
in the long run if not supported by solid bony fusion. If healing is delayed
or does not occur, the implant may eventually bend, migrate and/or break.
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. TThese
conditions are described in the section “INDICATIONS, CONTRAINDICATIONS
AND POTENTIAL ADVERSE EVENTS”. The safety and eectiveness of these
devices for any other conditions are unknown.
The safety and eectiveness of this device has not been established for use
as part of a growing rod construct. This device is only intended to be used
when denitive fusion is being performed at all instrumented levels.
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.
PRECAUTION
The implantation of pedicle screw spinal systems should only be
performed by experienced spinal surgeons with specic 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 in the medical and surgical aspects of
the implant, and be aware of its mechanical limitations. 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 noncompliance with postoperative instructions could lead to
failure of the implant and possible need thereafter for additional surgery
to remove the device.
PASS® XS spinal systems should not be used with components of any other
system or manufacturers.
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. Correct selection
of the implant size and shape for each patient is critical to the success
of the procedure, it is important to refer to the surgical technique. Once
implanted, the devices 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 stresses on the implant. Otherwise, excessive loading is placed
on the device, and may increase the attendant risks of fracture and/or
deformation of the implant and may eventually lead to a 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).
The benets of spinal fusion using pedicle screw xation systems have not
been fully established in patients with a stable spinal column.
OTHER PRECAUTIONS
For traceability reasons, the rods should not be cut.
PREOPERATIVE PRECAUTIONS
1. Only patients meeting the criteria described in section «INDICATIONS»
should be selected.
2. Patients meeting the criteria described in section «CONTRAINDICATIONS»
should not be selected.
3. Use extreme care in handling and storing the implants. Implants should
not be scratched or damaged.
4. Prior to performing the surgery, the surgeon should determine the
type of construction that he will use and ensure that an adequate
implant range is available, as well as associated instruments. He should
personally handle all the components before use in order to be perfectly
familiar with the device and instruments.
5. Unless the components are supplied sterile, they should be cleaned and
sterilized before use. Extra sterile components should be available in
case of an unexpected need.
MEDICREA® INTERNATIONALS.A. INSTRUMENT SELECTION
Selecting the appropriate instruments is critical to the success of the
procedure. It is compulsory to use the set of instruments MEDICREA®
INTERNATIONALS.A. supplied for the implantation of the PASS® XS spinal
system. Do not use any other instrument unless stated by MEDICREA®
INTERNATIONALS.A..
INTRAOPERATIVE PRECAUTIONS
1. Instructions in the surgical technique should be strictly followed.
Breaking, slipping or incorrect use of the implants may injure the
patient or the medical operating sta.
2. 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.
3. 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.
4. Repeated or excessive bending of the rods should be avoided as much as
possible. Do not reverse the bend of an already bent rod.
5. To achieve solid bony fusion, bone grafting is necessary, using an
autograft.
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 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. To increase the success rate of the surgery, the patient should be aware
of the risks in order to restrict his/her physical activities, particularly
those involving torsion and lifting, and give up participation in sports.
3. The patient should be advised against alcohol or tobacco use during
consolidation of the bone graft.
4. Absence of bone fusion will result in repeated and excessive stresses
on the implant. Through fatigue, these stresses may nally cause
deformation, loosening or breakage of the device. Fusion should be
assessed radiographically. In case of persistent nonunion, or if the
components begin to loosen, bend and/or break, the device should
be revised and/or removed without delay, before any serious damage
occurs.
5. 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).
6. MEDICREA® INTERNATIONALS.A. internal xation systems have been
designed to provide stabilization of the operative site during normal
bone consolidation. After solid fusion occurs, the device is no longer
required and removal is possible, this is the surgeon’s decision.
7. Once removed, implant should be processed in a way to prevent 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 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® INTERNATIONALS.A.. Furthermore, malfunction or suspected
malfunction of the implanted device should be reported to the distributor
or MEDICREA® INTERNATIONAL S.A.. Any serious undesirable eect or
death that might have been provoked by incorrect functioning of a
MEDICREA® INTERNATIONALS.A. device, should be immediately reported
to the distributor or to MEDICREA® INTERNATIONALS.A. 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
12months.
The specic indications for the implants are described in the paragraph
«INDICATIONS, CONTRAINDICATIONS AND POTENTIAL UNDESIRABLE
EFFECTS».
The patient should be aware that this device cannot be expected to
indenitely withstand the activity level and loads of normal healthy
bone. Moreover, the human body anatomy limits the dimensions of
any articial consolidation device used in surgery. This geometrical
limitation increases the possibilities of mechanical complications such
as loosening, deformation, or breaking. These complications may lead to
an additional surgical operation to remove or possibly replace the device.
It is therefore essential to follow physician’s instructions very carefully
regarding postoperative behavior. Patient activities must be limited
according to physician’s recommendations. Immobilizing aids or other
devices intended to partially or totally support weight are to be used on
the recommendation of physician. By following these instructions patient
will increase chances of a successful outcome, and will reduce the potential
injuries and/or additional surgery.
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:
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.
EN INSTRUCTIONS FOR USE
VALID ONLY FOR THE USA
REFERENCE : C19D01002 - Version 03
Last revised update: 07/2021
Symbols
Do not reuse
Do not resterilize
Caution
Consult instructions for use
Non sterile
Do not use if package is damaged
Catalogue number
Batch code
Quantity
QTY
Use by date
Manufacturer
Date of manufacture
Caution: Caution: Federal (USA) law restricts
Rx Only
the sale and/or the use of this device to or on
the order of a physician.
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