Medtronic B08106005S Instructions for Use

IMPORTANT MEDICAL INFORMATION

LigaPASS®spinal system

US – VALID ONLY FOR THE USA

Manufa ctured by :
MEDICREA®INT ERNATIONALS.A. (Customer service department)
5389 Route d e Strasbourg – Va ncia – 69140 Rillieu x la Pape – France

Phone: [phone]. Fax: [phone]

E-mail: [e-mail]

CAUTION: USA F ederal law r estric ts the sal e and/or the u se of this de vice to or on th e
order o f a physic ian.

MEDICREA® INTERNATIONALS.A.

INTENDED USE

The LigaPASS® MEDICREA® INTERNATIONAL S.A. spinal system is designed to
contribute to correction and surgical stabilization of the thoracic and/or lumbar
spine. This device should not be used in the cervical region. These implants are
designed to stabilize the spine during normal development of solid bony
consolidation. After solid fusion occurs, the presence of the device is no longer
required and removal is possible.

DESCRIPTION

The LigaPASS® MEDICREA®INTERNATIONALS.A. spinal system is composed of four
components, a connector, two set screws and a band.
The LigaPASS® system is designed to stabilize a vertebra in the same manner as a hook
around the vertebra during development of solid bony fusion. The LigaPASS® system
must be implanted via a posterior approach to complete a thoraco-lumbar xation
system as the PASSLP® MEDICREA®INTERNATIONALS.A. spinal system or CD Horizon™
Spinal System.
The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to
ISO5832-3 specications and ASTM F136, with the exception of the band which is
manufactured in polyethylene terephtalate (PET) and titanium T40 conforming to
ISO5832-2 specications and ASTM F67.
As any orthopaedic implant, these implants must not be reused. For a complete guide
of the system, please refer to surgical technique manual for specic instructions.

INDICATIONS, CONTRAINDICATIONS AND POTENTIAL ADVERSE EFFECTS

Indications

The LigaPASS® system is an implant for use in orthopaedic surgery. The system is
intended to provide temporary stabilization as a bone anchor during the development
of solid bony fusion and aid in the repair of bone fractures. The indications for use are
as follows:

- Spinal trauma surgery, used in sublaminar or facet wiring techniques;

- Spinal reconstructive surgery, incorporated into constructs for the purpose of
correction of spinal deformities such as idiopathic and neuromuscular scoliosis in
patients 8 years of age and older, adult scoliosis and kyphosis;

- Spinal degenerative surgery, as an adjunct to spinal fusions.

The LigaPASS® system may also be used in conjunction with other medical grade
implants made of titanium or cobalt-chrome alloy whenever “wiring” may help secure
the attachment of other implants.
WARNING: The system must not be used with rod diameters inferior to 4.5mm or
superior to 6mm.
Caution: to be used by or on the order of a licensed physician. Implantation
should only be performed by a surgeon who is familiar with the device, its intended
use, dedicated instruments, and understands all aspects of the surgical procedure.

Contraindications

The non-exhaustive list of contraindications includes:

1. Any signs of local or systemic infection or inammation.

2. Pathologic obesity.

3. Pregnancy.

4. Any medical or surgical condition which would compromise the success of the
procedure (e.g. malignant tumors or severe developmental anomalies, elevation of
erythrocyte sedimentation rate (ESR) that is not attributable to other pathologies,
increase or decrease in white blood cell count).

5. Allergies and intolerance (suspected or known) to materials.

6. Any condition that does not require bone grafting or bone fusion.

7. Any patient with poor tissue coverage at the operative site.

8. All cases which do not come under the above mentioned “Indications”.

9. Patients who are unwilling to follow postoperative instructions.

10. 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 eects

In addition to the risks associated with surgery of the spine without instrumentation,
a number of possible adverse events may occur with posterior 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 vertebrae.

4. Allergic reaction to the implanted materials and the presence of micro-particles
around the implants (metallosis).

5. Cutaneous problems with the components in areas where the tissue cover is
insucient accompanied by pain and abnormal sensations due to the volume of
the device.

6. Postoperative loss of correction and/or reduction of the spine, partial or total loss of
the corrections achieved.

7. Deep or supercial infection with an inammatory reaction.

8. Pseudarthrosis.

9. Neurological complications

10. Leakage of cerebrospinal uid.

11. Gastrointestinal disorders, urinary tract disturbances, and/or reproductive
disorders including sterility, impotence.

12. Excessive intraoperative bleeding and/or hematomas.

13. Growth arrest in fused spinal segments.

14. Vascular disorders (thrombosis) and/or pulmonary embolism.

15. Patient’s inability to resume normal activities of daily living.

16. Disease (deterioration) of the adjacent segments to the assembly.

17. Reduction in bone density caused by altered distribution of mechanical stresses.

18. Death.

NOTE: Some of the above adverse events may necessitate surgical revision.

IMPLANT INSERTION

The LigaPASS® device should be implanted 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 specically recommended in a MEDICREA®INTERNATIONALS.A. document as
the combination may be incompatible and cannot be guaranteed.
MEDICREA® INTERNATIONAL S.A. accepts no responsibility if non-associated
instruments are used.
Once the LigaPASS® system is in place, the unused portion of the band at the back of
the connector must be cut and removed from the patient.
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. 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®INTERNATIONALS.A..
Any damaged product or any product which packaging is damaged must not be used
and must be returned to MEDICREA®INTERNATIONALS.A..

STORAGE AND HANDLING

No special storage conditions are required.

INSPECTION OF STERILE IMPLANTS

MEDICREA® INTERNATIONAL S.A. implants delivered sterile have been sterilized by
gamma irradiation. 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 if the expiry date marked on the packaging has not passed.
MEDICREA®INTERNATIONALS.A. accepts no responsibility if implants are used when
expiry date has passed.
If the packaging is damaged or torn, the implant must not be resterilized and should
be returned to MEDICREA®INTERNATIONALS.A..

WARNING: Do not resterilize an implant that has already been sterilized.

DECONTAMINATION, CLEANING AND STERILIZATION OF IMPLANTS DELIVERED AS
NON-STERILE

It is imperative that all non-sterile implantable devices which have been removed
from their packaging, must 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.

WARNINGS

- Do not use caustic soda.

- Do not use saline or sodium hypochlorite solution (bleach) because they encourage
corrosion.

- Do not use solutions containing aldehyde.

- Comply with the instructions and warnings provided by the suppliers of the
cleansing and disinfection products.

- Special precautions linked to unconventional transmissible agents: for some risk
classications, the World Health Organization (WHO) or the relevant authorities
recommend special procedures to inactivate unconventional transmissible agents
MEDICREA® INTERNATIONAL S.A. recommends that these procedures should be
followed. For further information, please consult the local regulations and those
from the WHO.

- The procedure for medical devices described below must be carried out in accordance
with the sta protection rules adopted by the health-care facility, to minimize the
sta exposure to pathogenic agents.

Preparation for cleaning

Cleaning is an essential step to ensure that sterilization is eective.
Failure to carry out the steps described below can jeopardize the successful sterilization
of MEDICREA® INTERNATIONAL S.A. medical devices.
Fragile implants should be cleaned separately.

Cleaning procedure validated by MEDICREA®INTERNATIONAL S.A.

The cleaning step cannot replace sterilization: all MEDICREA® INTERNATIONAL S.A.
implants should be sterilized before surgery according to the method described in
paragraph “sterilization”.
Cleaning agents should have the following characteristics: microbiological properties,
a low lather potential to facilitate rinsing, a neutral pH to minimize risks of corrosion.
It is recommended to follow manufacturer’s instructions for preparation and use of the
solutions. The washing tanks should be relled for each use unless otherwise specied
by the manufacturer or if eectiveness of the tank is available.
To thoroughly clean the implants, the instructions below must be followed:

1. Immerse the implants in a washing bath (Microbicide agent) with heating (109.4°F
+/- 41°F) and ultrasound (40Khz) for 15 minutes (+/- 30 seconds).

2. Immerse the implant in a rinsing bath with tap water and at room temperature for
5 minutes (+/- 30 seconds).

3. Immerse the implants in a rinsing bath with distilled water and ultrasound (40Khz)
with heating (122 °F -41°F/+50°F) for 5 minutes (+/- 30 seconds). Place the
implants in the baskets ensuring as much as possible that the dicult to-reach
areas are exposed to the ultrasound.

4. Place the implants in the drying heat chamber with heating (230°F -41°F/+50°F)
for 10 minutes (+/- 30 seconds).

Inspecting the device

After decontamination and cleaning, the care unit should carry out a visual inspection
of 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. It 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

To prevent transmission of the Creutzfeldt-Jakob disease and other unconventional
transmissible agents, the sterilization cycle with 134°C / 274°F for 18 minutes is
recommended by MEDICREA®INTERNATIONALS.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® INTERNATIONALS.A. from any
responsibility.

Temperature

134°C / 274°F 18 minutes

132°C / 270°F 4 minutes

Duration of

treatment

Drying Time

20-30 minutes

WARNINGS AND PRECAUTIONS

Every surgical procedure involves a risk of failure, particularly in spine surgeries. Any
concurrent condition may adversely aect the outcome, in particular when patient’s
general state of health is deteriorated. This device should be associated with bone
graft, and 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 union. If
healing is delayed or does not occur, the implant may eventually bend, migrate and/or
break.
Strict adherence to the surgical protocol, both preoperatively and intraoperatively,
proper understanding of the surgical techniques, and correct selection and positioning
of the implants are critical to the success of the surgery. Furthermore, correct patient
selection and patient’s compliance are inuential factors aecting the nal outcome.
High non-union rates have been reported in heavy smokers; these patients should be
aware of this risk and duly informed of the associated complications. Obesity,
malnutrition, alcoholism, insucient quality of bone support, muscle deciency, and/
or paralysis have been found to signicantly increase the incidence of non-union.

MRI SAFETY INFORMATION

The LigaPASS® has not been evaluated for safety and compatibility in the
MR

environment. It has not been tested for heating, migration, or image artifact in the

MR environment. The safety of the LigaPASS® 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. Otherwise, excessive loading is placed on the internal
xation 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.
Any use in regions which are not recommended by MEDICREA®INTERNATIONALS.A.
will not be guaranteed.

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 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.

5. 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®INTERNATIONALS.A. instrument selection:

Selection of the appropriate instruments is critical to the success of the procedure. It is
compulsory to use the set of instruments MEDICREA®INTERNATIONALS.A. supplied for
the implantation of the LigaPASS® spinal system. Do not use any other instrument
unless stated by MEDICREA®INTERNATIONALS.A..

Intraoperative precautions

1. Instructions in the surgical technique should be strictly followed. Breaking,
slipping or incorrect use of the instruments or implants may injure the patient or
the medical operating sta.

2. If a problem occurs while handling the implants during the surgery, 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 have the correct dimensions
(length, diameter) to prevent possible nerves damage, a hemorrhage or avulsion.
Any nerve injury may result in a neural decit.

4. 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
patient should be aware that complications such as deformation, loosening and/or
fracture of the device may results from early weight bearing or heavy physical
activity during the postoperative rehabilitation period. This risk is further increased
in active patients, or in patients who are weakened, mentally compromised, or
unable to use an external support. Patients should be warned to avoid falls,
jumping, and shocks to the operated area.

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 warned against alcohol or tobacco use during healing of the
bone graft.

4. Absence of bone fusion will result in repeated and excessive stresses on the internal
xation devices. 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. The MEDICREA®INTERNATIONALS.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, implants should be processed in a way to prevent reuse in another
surgical 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 satised
with the product quality, identication, durability, reliability, safety, ecacy and/or
performance, should contact the distributor or MEDICREA® INTERNATIONAL S.A..
Furthermore, malfunction or suspected malfunction of the implanted device should
be reported to the distributor or MEDICREA® INTERNATIONAL S.A.. Any serious
undesirable eect or death that might have been provoked by incorrect functioning of
a MEDICREA® INTERNATIONALS.A. device, should be immediately reported to the
distributor or to MEDICREA®INTERNATIONALS.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®INTERNATIONALS.A..

PATIENT INFORMATION

MEDICREA® INTERNATIONAL S.A. spinal osteosynthesis implants are designed to
contribute to correction and surgical stabilization of the thoracic and lumbar spine
only. This device should not be used in the cervical region. These implants are designed
to stabilize the spine during the normal development of solid bony consolidation. The
specic indications of the implants are described in the paragraph “INDICATIONS,
CONTRAINDICATIONS AND POTENTIAL ADVERSE EFFECTS”.
The patient should be aware that this device cannot be expected to indenitely
withstand the activity level and loads of normal healthy bone. Moreover, the human
body anatomy limits the dimensions of any articial 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 specied in
this document.

EN INSTRUCTIONS FOR USE

VALID ONLY FOR THE USA

REFERENCE : C08D01002 - Version 07

Last revised update: 04/2021

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

Catalogue number

Batch number

Quantity

QTY

Use by date

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