IFU for Spinal Implant

Instruction concerning Orthopaedic Implants (Spinal discussion postoperatively & the necessity should be
Implant) made by Bombay Ortho Industries. focused for periodic medical follow-up.
 The Correct selection of the product is extremely
Located at G/551, Metoda, Lodhika G.I.D.C., Kalawad important. The product should be used in the correct
Road, Gate No. 3, Rajkot - 360021, Gujarat, India. anatomical location, consistent with the accepted
Tele/fax No.: +91-9978928286 standard for the internal fixation. Failure to use the
appropriate product for the application may result in a
CONTENTS
premature clinical failure. Failure to use the proper
The Device package contains single use implant (Spinal
component to ensure adequate blood supply & provide
Implant) of the Bombay Ortho Industries
rigid fixation may result in loosening, bending or
cracking of the product and/ or bone fracture.
DESCRIPTION
 For selection of suitable implants, its accessories &
The Spinal Implant are single use device supplied Non-sterile.
related devices, kindly refer a product combination
The devices are available in SS 316L & Titanium Grade 23
chart available on our website.
with different sizes.
 The Product Combination Chart and Surgical
The Product catalogue are available on the company
Technique for the products are available on the
website https://bombayortho.com/
company website
Product Combination Chart
FUNCTIONAL CHARACTERISTICS
https://bombayortho.com/combination-chart/spine-
Spinal Implants are use for stabilization of the spine and can be
system-for-product-combination-chart/
classified as those placed within the inter-body space (the disc
Surgical Techniques-
space) or placed directly onto the spine for stabilization.
https://bombayortho.com/combination-chart/surgical-
technique/
INTENDED USE
Spinal Implants are used in the surgical procedures related to
CONTRAINDICATIONS
the spinal injuries and spinal diseases.
Do not use the Spinal Implant in cases of:
 Inadequate bone quantity and/or bone quality
Correct selection of the implants is extremely important:
 Hypersensitivity to metal or allergic reaction
 The selection of the proper size, shape & design of the
implant for each patient is extremely important to the  Early or Late Infection, both deep and / or superficial
success of the procedure.  Patients with limited blood supply
 Responsibility of the proper selection of patients,  Patient within whom co-operation or mental
adequate training, experience in the choice, placement competence is lacking, thereby reducing patient
of the implant & the decision to leave or remove compliance
implant postoperatively, rests with the surgeon.
 Our Spinal Implant are available in variety of ADVERSE REACTIONS
Adverse reactions may include but are not limited to:
configurations, these shall be used in combination
with related corresponding implants & instruments  Clinical failure (i.e. pain or injury) due to bending,
made by Bombay Ortho Industries only. loosening, breakage of implant, loose fixation,
dislocation and/or migration
 The product should be used in combination with the
devices made up similar material only. .(Titanium  Pain, discomfort, and/or abnormal sensations due to
Gr.23 implants with Titanium Gr.23 & SS 316L the presence of the implant.
implants with SS 316L) as the different materials  Primary and/or secondary infections.
exhibit different properties. Mixing of metals may  Allergic reactions to implant material.
cause inflammatory response, metal sensitivity  Necrosis of bone or decrease of bone density.
reactions, and/or long term detrimental systemic  Injury to vessels, nerves and organs.
effects. In addition, it can reduce the mechanical  Elevated fibrotic tissue reaction around the surgical
strength of the implant. area.
 The Surgeon should discuss the expectation of the  Malalignment can lead to injury to adjacent ligaments
surgery inherent the use of the product with the and bones.
patient. Particular attention should be given to a  Limb Shortening due to compression of the fracture or
Bone Resorption

Document Number: 08-BOI-TCF-17-003 Revision: 05 Issue No.: 02 Effective Date: 17.08.2020

 IFU for Spinal Implant
PRE-OPERATIVE
 Keep the instructions for use accessible to all staff.
SAFETY PRECAUTIONS  The operating surgeon must have a thorough
 The Product should only be used by the medical understanding of both, the hands-on and conceptual
personnel who hold relevant qualification. aspects of the established operating techniques. Proper
 Never use the product that has been damaged by surgical performance of the implantation is the
Improper handling in the hospital or in any other way. responsibility of the operating surgeon. The operating
 Never reuse an implant. Although the implant appears surgeon draws up an operation plan specifying and
to be undamaged, previous stresses may have created documenting the following:
non-visible damage that could result in implant  Implant component(s) and their dimensions.
failure.  Determination of intra-operative orientation
 Safety Precaution for Special Cases points.
Pregnant Women The following conditions must be fulfilled prior to application:
 Ensure that there should be less blood loss during  All required implant components are sterilized and
the surgery. readily available.
 General Anaesthesia should not be used in such  All requisite sterile implantation instruments must be
case. available and in working order.
 Operational environment must be free from  Highly aseptic operating conditions are present.
radiation.
Infant / Children Sterilization: All Single use NON-STERILE implants and
 Ensure that there should be less blood loss during
instrument used in the surgery must be cleaned & Sterile prior
the surgery.
to use.
 Operational environment must be free from
Remove plastic packing of implant before cleaning.
radiation.
Polymorbid & Breastfeeding Women
Cleaning Procedure:
 On Polymorbid patients and breastfeeding
New products must be carefully cleaned before initial
women, the implant shall be used at the
sterilization. Only trained personnel must perform cleaning
discretion of Orthopedic Surgeon.
Equipment: various sized soft-bristled brushes, lint-free cloths,
syringes, pipettes and/or water jet, neutral enzymatic cleaner or
HOW SUPPLIED/STORAGE:
neutral detergent with a pH 7.
The implants are individually packed in protective packaging
 Rinse Implants under running cold tap water for a
that is labelled to its contents properly. All Single use Non-
minimum of two minutes. Use a soft-bristled brush to
sterile implants are supplied.
clean the Implants.
 Implants should be stored in the original protective
packaging.  Soak Implants in a neutral pH enzymatic cleaner or
 Store the implants in a dry and dust-free place detergent solution for a minimum of ten minutes.
(standard hospital environment). Follow the enzymatic cleaner or detergent
manufacturer’s instructions for use for correct
INSPECTION: exposure time, temperature, water quality, and
Before use, inspect the box carefully. Do not use when concentration.
 Implants has scratches & damage  Rinse Implants with cold water for a minimum of two
 Improper threads with damages minutes. Use a syringe, pipette, or water jet to flush
 Prior to surgery check suitability of fixation of this lumens, channels, and other hard to reach areas.
implant with its corresponding implant, and also
 Manually clean Implants for a minimum of five
ensure strength of whole assembly.
minutes in a freshly prepared neutral pH enzymatic
OPERATING INSTRUCTIONS cleaner or detergent solution using a soft-bristled
 The Bombay Ortho Industries implants should be brush. Clean Implants under water to prevent
implanted only with the related corresponding aerosolization of contaminants.
instruments made by Bombay Ortho Industries. Note: Freshly prepared solution is a newly-made,
 Also ensure the availability of same implant as clean solution.
standby.  Rinse Implants thoroughly with deionized (DI) or
 Surgeon should document the implant details (name, purified (PURW) water for a minimum of two
item, number, lot number) in surgery record.

Document Number: 08-BOI-TCF-17-003 Revision: 05 Issue No.: 02 Effective Date: 17.08.2020

 IFU for Spinal Implant
minutes. Use a syringe, pipette, or water jet to flush  Corrective surgery may be necessary if the implant
lumens and channels. fails.
 Visually inspect Implants.  The patient must have his/her physician to carry out
 Perform a final rinse on Implants using DI or PURW follow-up examinations of the implants at regular
water. intervals.
 Dry Implants using a clean, soft, lint-free cloth or
clean compressed air. INTRA-OPERATIVE
Note: Cleaning Agent Information: We used the following  Prior to use, verify the integrity of the implant.
cleaning agents during internal processes of these cleaning  Modification of the Implant Set is not allowed.
recommendations. These cleaning agents are not listed in  Extreme care and caution should be used around the
preference to other available cleaning agents which may spinal cord and nerve roots. Damage to the nerves will
perform satisfactorily- neutral pH enzymatic detergents (e.g. cause loss of neurological functions.
Prolystica 2X Concentrate Enzymatic Cleaner, Enzol,  Bone graft must be placed in the area to be fused and
Endozime, and Neodisher Medizym) and neutral pH detergents graft material must extend from the upper to the lower
(e.g. Prolystica 2X Neutral Detergent). vertebrae being fused.
 Bone cement should not be used because the safety
We are suggesting following parameter for the sterilization;
and the effectiveness of bone cement has not been
Method Tempe Exposure Pressure determined for spinal uses.
rature time
Steam 121 15 103421  Before closing the soft tissues, provisionally tighten
(autoclave) Deg C. Minutes Pa / 0.1 all of set screws, especially screws or set screws that
MPa / 15 have a break off feature. Once this is completed go
psi back and firmly tighten all of the screws and set
Note: Recommended Steam Sterilizer (Autoclave) is Class B. screws.
Prior to steam sterilization, wrap the product in a plain  Recheck the tightness of all screws after finishing to
paper. made sure that none loosened during the tightening of
the other set screws or screws. Failure to do so may
WARNING: cause loosening of the other components.
The use of implants for surgery other than those for which they  Before locking the screw to the plate, the bone has to
are intended may result in damage/ breakage of implants or be correctly repositioned
patient injury.
 The operating surgeon and operating room team must POST-OPERATIVE
be thoroughly familiar with the operating technique,  Reiterate preoperative instructions to the patient.
as well as the range of implants and instruments to be  During the post-operative phase, in addition to
applied. Complete information on these subjects must mobility it is of vital importance that the physician
be readily available at the workplace. keeps the patient well informed about post-surgical
 The operating surgeon must be especially trained in behavioral requirements.
orthopedic surgery, biomechanical principles of the  Ensure that the patient is aware of physical activity
skeleton, and the relevant operating techniques. restrictions and possible adverse reactions.
 The patient is aware of the risks associated with
general surgery, orthopedic surgery, and with general IMPLANT REMOVAL
anesthesia.  The implant removal is most recommended in the
 The patient has been informed about the advantages surgeries where implant is placed near to or on the
and disadvantages of the implant & implantation moving parts of the body, some examples include, but
procedure and about possible alternative treatments. not limited to ankle, olecranon and femoral IM nails.
 The implant can be failed due to excessive load, wear  The decision of implant removal solely depends on the
and tear or infection. surgeon, based on age of patient, severity of the
 The service life of the implant is determined by body injury, clinical condition of the patient &
weight and physical activity. The implant must not be consideration of the post-surgery complication of
subjected to overload too early through extreme strain, implant removal.
work-related or athletic activities.  Following are the indication of implant removal
decision:

Document Number: 08-BOI-TCF-17-003 Revision: 05 Issue No.: 02 Effective Date: 17.08.2020

 IFU for Spinal Implant
 Choice of Patient
 Doctor’s Advice based on the clinical condition CLINICAL EVALUATION OF SPINAL IMPLANT
of the patient  The Bombay Ortho Industries Spinal Implant is
 Deep Wound Infection/Bone Atrophy clinically safe, and effective in use as discussed and
 Growing Skeleton proved up to the mark in the clinical evaluation of the
 Tenosynovitis device.
 Intra-Articular Material DO NOT REUSE AND RESTERILE IMPLANTS
 Post – traumatic Arthritis  Used implants which appear undamaged may have
 Avascular Necrosis internal and external defects. It is possible that individual
 Intractable Pain stress analysis of every part may fail to reveal the
 Perforating Material accumulated stress on the metals as a result of use within
 Infection the body. This may ultimately lead to implant failure.
 Paresthesia  Once an implant comes in contact with body fluids, it is
 Removal of Implant may cause the risk of re-fracture, contaminated with possible allergens and pathogens.
neurovascular injury, impaired wound healing, post- Resterilization by autoclave will not guarantee the
operative bleeding & infection. product to be 100% free from microbes.
 Bone in-growth and wear of the implant can make the
removal difficult, leading to incomplete removal of DISPOSAL OF SPINAL IMPLANT
the implant.  Please note that using a single use device (SUD)
 While the physician makes the final decision on when which comes into contact with human blood or tissue
to remove the implant, it is advisable – if possible and constitutes, these device may be a potential biohazard
appropriate for the individual patient – to remove and should be handled in accordance with accepted
fixation products after the healing process is complete. medical practice and applicable local and national
This holds true particularly for young and active requirements.
patients.

MRI SAFETY INFORMATION

 Bombay Ortho Industries implants are manufactured
from SS 316L & Titanium Grade 23 material, both are
non-magnetic material, hence it do not pose any safety
risk.
 Patients should be directed to seek a medical opinion
before entering potentially adverse environments that
could affect the performance of the implants, such as
electromagnetic or magnetic fields, including a
magnetic fields, including a magnetic resonance
environment.
 The Bombay Ortho Industries implants has not been
evaluated for safety and compatibility in the MR
environment but on the basis of literature study below
mentioned points can be taken care during MRI
 The minimum recommended time after the
implantation that allows patients to safely
undergo MRI examination or allowing the
patient or an individual to enter the MRI
environment is 6 (six) weeks.
 The maximum recommended time limit for MRI
examination in patients implanted with the
evaluated device is 30 min with a scanner
operating at 1.5T (Tesla) or less.

Document Number: 08-BOI-TCF-17-003 Revision: 05 Issue No.: 02 Effective Date: 17.08.2020

 IFU for Spinal Implant
FOR FURTHER INFORMATION
Please contact Bombay Ortho Industries in case of any Query, Complain or Adverse Effect
Email: bombayortho@gmail.com, Telephone: + 91-9978928286

Non Sterile

Indicates a medical device that has not been subjected to

a sterilization process.

Consult Instructions For Use

Indicates the need for the user to consult the instructions

for use.

Do not re-use

Indicates a medical device that is intended for one use or

for use on a single patient during a single procedure.

Caution

Indicates the need for the user to consult the instructions

for use for important cautionary information such as
warnings and precautions that cannot, for a variety of
reasons, be presented on the medical device itself.

Do not use if package is damaged

Indicates a medical device that should not be used if the

package has been damaged or opened.

Keep Dry

Indicates a medical device that needs to be protected

from moisture.

Keep away from Sunlight

Indicates a medical device that needs protection from

light sources.

Manufacturer

Indicates the medical device manufacturer, as defined in

EU Directives 93/42/EEC.

Bombay Ortho Industries.

G/551, Metoda, Lodhika G.I.D.C., Kalawad Road, Gate

No. 3,Rajkot - 360021,India.

Tele/fax No.: +91-9978928286

Document Number: 08-BOI-TCF-17-003 Revision: 05 Issue No.: 02 Effective Date: 17.08.2020

 IFU for Spinal Implant
Date Of Manufacture

Indicates the date when the medical device was

manufactured.
Authorized Representative in the European
Community

Indicates the Authorized representative in the European

Community.

CMC Medical Devices & Drugs S.L

C/HoracioLengo N° 18, CP 29006,
Malaga, Spain
Tel: +34 951 214 054
Email: info@cmcmedicaldevices.com
Catalogue Number

Indicates the manufacturer's catalogue number so that the

medical device can be identified.
Batch Code

Indicates the manufacturer's batch code so that the batch

or lot can be identified.

CE marking with Notified Body Number

Document Number: 08-BOI-TCF-17-003 Revision: 05 Issue No.: 02 Effective Date: 17.08.2020