1.
IMPORTANT MEDICAL INFORMATION
PASSOCT™ spinal system
EN / US - VALID ONLY FOR THE USA
Manufactured by:
MEDICREA™ INTERNATIONALS. 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: FEDERAL (USA) LAW RESTRICTS THE SALE AND/OR THE
USE OF THI S DEVICE TO OR ON T HE ORDER OF A PHYS ICIAN.
DESCRIPTION
The PASS OCT™ spinal system is a posterior system composed of a
variety of shapes and sizes of rods, hooks, polyaxial screws, occipital
plates, occipital bone screws, and connection components, which can
be rigidly locked to the rod in a variety of congurations. See package
insert of the system for labeling limitations.
The implants are manufactured in titanium alloy Ti-6Al-4V ELI
conforming to ISO 5832-3 specications and ASTM F136 specications,
Grade Titanium conforming to ASTM F67 and ISO 5832-2, Cobaltchromium molybdenum alloy Co-Cr28Mo6 according to ISO5832-12
and ASTM F1537 and in PEEK OPTIMA LT1 conforming to ASTM F2026
specications.
Never use stainless steel and titanium components in the same
construct.
To achieve best results, do not use any of the PASSOCT™ spinal system
implant with components from any other systems or manufacturers
unless this is specically labeled in a MEDICREA™ INTERNATIONALS.A.
document. As any othopaedic implant, these implants must not be
reused. For a complete guide to the system, it is important to refer to
the surgical technique.
INDICATIONS
INDICATION FOR USE
The PASSOCT ™ spinal system is intended to provide immobilization and
stabili zation of spinal se gments as an adjunc t to fusion for the f ollowing
acute and chronic instabilities of the craniocervical junct ion, the cer vical
spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal
fractures and/or traumatic dislocations; instability or deformity; failed
previous fusions (e.g., pseudarthrosis); tumors involving the cervical
spine; and degenerative disease, including intractable radiculopathy
and/ or myelopathy, neck and/or arm pain of discogenic origin as
conrmed by radiographic studies, and degenerative disease of the
facets with instability. The PASSOCT™ spinal system is also intended
to restore the integrity of the spinal column even in the absence of
fusion for a limited time period in patients with advanced stage tumors
involving the cervical spine in whom life expectancy is of insucient
duration to permit achievement of fusion.
In order to achieve additional levels of xation, the PASS OCT™ spinal
system may be connected to the PASS LP™ spinal system rods with the
dual diameter rods or dominos. Refer to the PASS LP™ spinal system
package i nsert for a list o f the PASSLP™ spinal syste m indications of us e.
PRECAUTION
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 noncompliance
with postoperative instructions could lead to failure of the implant and
possibl e need thereafte r for additional sur gery to remove the de vice.
WARNING: This device is not approved for screw attachment or xation
to the posterior elements (pedicles) of lower thoracic (T4-T12), or lumbar
spine.
WARNING: In the USA, this product has labeling limitations. See package
insert for complete information.
MEDICREA™ INTERNATIONALS.A.
PRECAUTION
Pre-operative planning prior to implantation of posterior cervical lateral
mass and pedicle screw spinal systems should include review of crosssectional imaging studies (e.g., CT and/or MRI imaging) to evaluate the
patient’s cervical anatomy including the transverse foramen and the
course of the vertebral arteries. If any ndings would compromise the
placement of lateral mass or pedicle screws, other surgical methods
should be considered. In addition, use of intraoperative imaging should
be conside red to guide and/or verif y device placemen t, as necessary.
PRECAUTION
Use of posterior cervical pedicle screw xation at the C3 through C6
spinal levels requires careful consideration and planning beyond that
required for lateral mass screws placed at these spinal levels, given the
proximit y of the vertebral arteries and neurologic structures in relation
to the cer vical pedicles at t hese levels.
PRECAUTION
The implantation of pedicle screw spinal systems should be performed
only by experienced spinal surgeons with specic training in the use of
this pedicle screw spinal system because this is a technically demanding
procedu re presenting a ris k of serious injur y to the patient.
IMPORTANT: TO BE USED BY OR ON THE PRESCRIPTION OF A
REGISTERED MEDICAL PRACTIONER.
This device should only be implanted by a surgeon who is familiar with
it, its use and ancillary instruments, and with the surgical procedure
required.
CONTRAINDICATIONS AND POSSIBLE ADVERSE EFFECTS
CONTRAINDICATIONS
The non-exhaustive list of contraindications includes:
2. Active infectious process or signicant risk of infection (immunocompromise)
3. Signs of local inammation.
4. Fever or leukocytosis.
5. Morbid obesity.
6. Pregnancy.
7. Mental illness.
8. Grossly distorted anatomy caused by congenital abnormalities.
9. Any other medical or surgical condition which would preclude the
potential benet of spinal implant surgery, such as the presence
of congenital abnormalities, elevation of sedimentation rate
unexplained by other diseases, elevation of white blood count (WBC),
or a marked left shift in the WBC dierential count.
10. Rapid joint disease, bone absorption, osteopenia, osteomalacia and/or
osteoporosis. Osteoporosis or osteopenia is a relative contraindication
since this condition may limit the degree of obtainable correction,
stabilization, and/or the amount of mechanical xation.
11. Suspected or documented metal allergy or intolerance.
12. Any case not needing a bone graft and fusion.
13. Any case where the implant components selected for use would be too
large or too small to achieve a successful result.
14. Any case that requires the mixing of metals from two dierent
components or systems.
15. Any patient having inadequate tissue coverage over the operative site
or inadequate bone stock or quality.
16. Any patient in which implant utilization would interfere with
anatomical structures or expected physiological performance.
17. Any patient unwilling to follow postoperative instructions.
18. Any case not described in the INDICATIONS.
Contraindications are similar to those applying to other similar devices.
This system is not designed, intended or sold for uses other than those
previously mentioned.
POTENTIAL UNDESIRABLE EFFECTS
Some unde sirable eect s are presented in t he literature:
1. Early or late loosening of any or all of the components.
2. Disassembly, bending, and/or breakage of any or all of the
components.
3. Infection.
4. Dural tears, pseudomeningocele, stula, persistent CSF leakage,
meningitis.
5. Loss of neurological function (e.g., sensory and/or motor), including
paralysis (complete or incomplete), dysesthesias, hyperesthesia,
anesthesia, paresthesia, appearance of radiculopathy, and/or the
development or continuation of pain, numbness, neuroma, spasms,
sensory loss, tingling sensation, and/or visual decits.
6. Scar formation possibly causing neurological compromise or
compression around nerves and/ or pain.
7. Hemorrhage, hematoma, occlusion, seroma, edema, hypertension,
embolism, stroke, excessive bleeding, phlebitis, wound necrosis,
wound dehiscence, damage to blood vessels.
8. Non-union (or pseudarthrosis). Delayed union or malunion.
9. Adjacent segment degeneration.
Others adverse events were not found in this literature but are potential
adverse events for spinal surgery:
1. Foreign body (allergic) reaction to implants, debris, corrosion products
(from crevice, fretting, and/or general corrosion), including metallosis,
staining, tumor formation, and/or autoimmune disease.
2. Pressure on the skin from component parts in patients with
inadequate tissue coverage over the implant possibly causing skin
penetration, irritation, brosis, necrosis, and/or pain. Bursitis. Tissue
or nerve damage caused by improper positioning and placement of
implants or instruments.
3. Post-operative change in spinal curvature, loss of correction, height,
and/or reduction.
4. Cauda equina syndrome, neuropathy, neurological decits (transient
or permanent), paraplegia, paraparesis, reex decits, irritation,
arachnoiditis, and/or muscle loss.
5. Fracture, micro-fracture, resorption, damage, or penetration of any
spinal bone (including pedicles, and/or vertebral body) and/or bone
graft or bone graft harvest site at, above, and/or below the level of
surgery. Retro-pulsed graft.
6. Herniated nucleus pulposus, disc disruption or degeneration at, above,
or below the level of surgery.
7. Cessation of any potential growth of the operated portion of the spine.
8. Loss of or increase in spinal mobility or function.
9. Inability to perform the activities of daily living.
10. Bone loss or decrease in bone density, possibly caused by stresses
shielding.
11. Graft donor site complications including pain, fracture, or wound
healing problems.
12. Change in mental status.
13. Death.
NOTE: Some of the above undesirable eects may necessitate surgical
revision.
IMPLANT INSERTION
I
mplants are inserted using instruments specially made for this purpose.
It is important to refer to the surgical technique of the implant and the
instructions for use of the instruments. The implants should not be used
with non-associated instruments, unless this is specically recommended
in a MEDICREA™ INTERNATIONALS.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 cont amination and loss o f integrity of i ts mechanical pr operties.
As the device is made from metal (Titanium Alloy, CoCr Alloy or CP
Titanium), interferences such as artifacts may be possible in MRI
scans. The PASS OCT™ spinal system has not been evaluated for safety
and compatibility in the magnetic resonance (MR) environment. The
PASSOCT™ spinal system has not been tested for heating or migration in
the MR environment.
PACKAGING
The packaging of each component should be intact at reception.
If a loaner kit or a consignment sets is used, components 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. All
devices which packaging is damaged must not be used and must be
returned to MEDICREA™ INTERNATIONAL S.A.. Any instrument that has
been in the operating theatre without packaging, must imperatively be
cleaned and then resterilized before handling, or return to MEDICREA™
INTERNATIONALS.A..
STORAGE AND HANDLING
No specia l storage conditi ons 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™ INTERNATIONALS.A. accepts no responsibility if
implant s are used when expi ry date has passe d.
If the packaging is damaged or torn, the implant must not be resterilized
and must be r eturned to MEDICR EA™ INTERNATIONALS.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 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 per formed 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 o r brushes) should also n ot be used.
WARNING: The use of cau stic soda is stri ctly prohibit ed.
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, washing and inspection, the implants are
sterilized by steam autoclaving, following the care unit’s internally
validated p rocedure whic h should take into acco unt the type of e quipment
and the ty pe and number of pro ducts presen t 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 cycle
descri bed in the table bel ow:
Method Cycle Temperature
Steam
Sterilizers and accessories such as sterilization wraps, sterilization
pouches, chemical indicators, biological indicators, and sterilization
casset tes must only be us ed if they have been FDA clea red for the selec ted
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.
WARNINGS AND PRECAUTIONS
WARNING
The safe ty and eec tiveness o f pedicle sc rew spinal sys tems have only be en
established for spinal conditions with signicant mechanical instabilit y or
deformity of the thoracic spine requiring fusion with instrumentation.
These conditions may be secondary to degenerative spondylolisthesis
with objective evidence of neurologic impairment, scoliosis, kyphosis,
failed previous fusion (pseudarthrosis), spondylolisthesis, spinal stenosis,
trauma (i.e. f racture or dislo cation), failed previ ous spine surgery, tum ors.
Based on the fatigue testing results, the physician/surgeon should
consider the levels of implantation, patient weight, patient activity level,
Pre-
vaccum
132° C 4 minutes
Durati on of
treatment
Dryi ng
Time
20-3 0
minutes
compliance of the patient, and other patient conditions which may have
an impac t on the perfor mance and results o f this system.
PRECAUTION
The MEDICREA™ INTERNATIONAL S.A. device placement should only be
performed by an experienced spinal surgeon or a neurosurgeon trained
in surgery of the spinal column. This technically demanding procedure
should be perfectly understood by the surgeon who should have
followed a specic training in the use of this implant. The surgeon must
be thoroughly knowledgeable in the medical and surgical aspec ts of the
implant, an d be aware of its mech anical limitati ons. The patient mus t also
be instructed in the implant limitations regarding weight bearing and
body stresses on the device 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
surger y to remove the device.
PASS OCT™ and PASS LP™ components can be used together, but the
MEDICREA™ INTERNATIONALS.A. PASSOCT™ spinal system should not be
used with components of other systems or manufacturers.
Some degree of corrosion occurs on all implanted metals and alloys.
Dissimilar metals in contact with each other can accelerate the corrosion
process reducing mechanical resistance of the implant. Do not mix
stainless steel and titanium implant components together in the same
spinal construct.
MRI SAFETY INFORMATION
The PASSOCT™ implants 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 safet y of the PASS OCT™
implants 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 sc ratches on their sur face should not b e used. Correct s election
of the impla nt size is critica l to the success of the pr ocedure. It is impo rtant
to refer to the surgical technique. Once implanted, the device is subjected
to repeated stress, and its strength is limited by the adaptation of its
geometry to the size and shape of human bones. Proper patient selection
criteria, correct implant positioning, and appropriate postoperative care
are there fore essential to m inimize stress es on the implant.
Otherwise, excessive loading is placed on the device, and may increase
the atte ndant risks of fr acture and/or def ormation of the imp lant and may
eventually lead to a loosening before bone union is achieved. This in turn
may cause da mage or necessita te premature remov al of the implant.
OTHER PRECAUTIONS
For traceability reasons, the rods should not be cut. Any use in regions
which are not recommended by MEDICREA™ INTERNATIONALS.A. will not
be guaranteed.
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 performimg 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 dedicated 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. INSTRUMENTS SELECTION:
Selection of 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 t he implantation o f the PASSOCT™ 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 instruments or 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 instruc tions and warnings given by the physician to
the patient, the patient’s ability and willingness to follow instructions are
among the most important aspects of successful bone healing.
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 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 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 the occurrence of consolidation, the device
serves no further useful function and may be removed; this is the
surgeon’s decision.
7. Once removed, implants 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™ 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 eec t or death that might have been induced
by incorrect functioning of a MEDICREA™ INTERNATIONAL S.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
componen t(s), as well as your full name an d address and the na ture of your
claim. Also, please specify whether a written report is re quested from the
distributor or MEDICREA™ INTERNATIONALS.A..
PATIENT INFORMATION
The MEDICREA™ INTERNATIONAL S.A. PASS OCT™ implants for spinal
osteosynthesis are designed to contribute to correction and surgical
stabilization of the occipito-cervico-thoracic spine only (occiput-T3). This
device should not be used in the inferior thoracic (T4-T12), lumbar and
sacral regions. These implants are designed to stabilize the spine during
normal development of solid bony consolidation.
The specic indications of the implants are described in sec tion
“INDICATIONS, CONTRAINDICATIONS AND POSSIBLE ADVERSE EFFECTS”.
The patient should be aware that this device cannot be expected to
indenitely withstand the ac tivit y 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 physican’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
complianc e with the recomme ndations of one of th e following two no rms:
S94-030 “ Sur gical implant s - Guide for the ret rieval, handling an d 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,
the dispos al must be carried out in accordance with the decree n°97-1048
dated 6 November 1997 relating to the disposal of healthcare was te with
an infec tious or similar ri sk and of anatomical sp ecimens.
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 : C17D01002 - Version 05
Last revised update: 08/2021
Symbols
Do not reuse
Do not resterilize
Caution
Consult instructions for use
Non sterile
Sterilized using irradiation
Do not use if package is damaged
Catalogue number
Batch code
QTY
Quantity
Dimension
DIM
Use by date
Manufacturer
Date of manufacture
Caution: Federal (USA) law restricts the sale and/or
Rx Only
the use of this device to or on the order of a physician.
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