Pyramesh™ Implant System M708348B871E Rev. A
2020-05-08
IMPORTANT INFORMATION ON THE PYRAMESH™ IMPLANT SYSTEM
PURPOSE
Pyramesh™ Implant System devices are intended for Vertebral body replacement to aid in surgical correction and stabilization
of the thoracic and lumbar spine.
DESCRIPTION
The Pyramesh™ Implant System device is a cylindrically-shaped implantable device with open ends and a hollow core
throughout its longitudinal axis. Pyramid-shaped openings are built into the wall of the device. These openings and the hollow
core allow grafting material to be placed inside the device to help achieve solid fusion. Contoured ends of the implant serve to
grip superior and inferior end plates when used for spinal indications, thus allowing expulsion resistance.
The device is made from commercially pure titanium and titanium alloy and is available in various sizes to match patients'
anatomical requirements.
When used as a vertebral body replacement device, the device is intended to be used with supplemental spinal fixation systems
cleared for use in the thoracolumbar spine. The device is not intended to be used as a stand-alone implant.
Do not use devices from any other manufacturer with Pyramesh™ Implant System devices. Stainless steel and titanium
implants are not compatible, nor are implants made from different metal alloys. Stainless steel and titanium implants must not
be used together in a construct. As with all orthopedic implants, implants may not be reused.
Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
Device lifetime for the Pyramesh™ Implant System is two years in which the device is expected to achieve its performance (e.g.
immobilization and stabilization as an adjunct to fusion) and maintain its safety until fusion occurs. After fusion, the device is
further designed and tested to survive the life of the patient.
INDICATIONS
Pyramesh™ Implant System devices are for use in the thoracolumbar spine (T1 to L5) to replace and restore the height of a
diseased or damaged vertebral body caused by tumor and/or fracture. Pyramesh™ Implant System devices are intended to be
used with supplemental fixation and allograft or autograft material may be used at the surgeon's discretion.
CONTRAINDICATIONS
Contraindications include:
▪ Infection local to the operative site.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Medical or surgical conditions which would preclude the potential benefit of spinal implant surgery, such as the presence of
tumors or congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood
count (WBC), or a marked left shift in the WBC differential count.
▪ Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication since this
condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.
▪ Suspected or documented metal allergy or intolerance.
▪ Cases needing to mix metals from different components.
▪ Patients having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality,
or anatomical definition.
▪ Cases not described in the indications.
▪ Patients unwilling to cooperate with postoperative instructions.
▪ Pediatric cases, nor where the patient still has general skeletal growth.
▪ Cases not needing a bone graft and fusion or where fracture healing is not required.
▪ Any time implant use would interfere with anatomical structures or expected physiological performance.
Contraindications of this device are consistent with those of other spinal systems.
Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device
include:
▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.
POTENTIAL ADVERSE EVENTS
All adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of possible adverse events or complications includes:
▪ Early or late loosening of components.
▪ Implant migration.
▪ Disassembly, bending, and/or breakage of components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products, including metallosis, staining, tumor formation
and/or autoimmune disease.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of devices.
▪ Loss of neurological function, including paralysis (complete or incomplete), dysesthesia, hyperesthesia, anesthesia,
paraesthesia, appearance of radiculopathy, and/or development or continuation of pain, numbness, neuroma, tingling
sensation, sensory loss, and/or spasms.
▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,
arachnoiditis, and/or muscle loss.
▪ Scar formation possibly causing neurological compromise around nerves and/or pain.
▪ Urinary retention, loss of bladder control, or other types of urological system compromise.
▪ Bone loss or decrease in bone density, possibly caused by stress shielding.
▪ Subsidence of the device into vertebral bodies.
▪ Postoperative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Loss of spinal mobility or function.
▪ Inability to perform activities of daily living.
▪ Non-union (or pseudarthrosis), delayed union, and/or mal-union.
▪ Fracture, microfracture, resorption, damage, penetration, and/or retropulsion of any spinal bone, of the bone graft, or at the
bone graft harvest site at, above, and/or below the level of surgery.
▪ Graft donor site complications including pain, fracture, infection, or wound healing problems.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Ileus, gastritis, bowel obstruction or other types of gastrointestinal system compromise.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, damage to blood
vessels, or cardiovascular system compromise.
▪ Wound necrosis or wound dehiscence.
▪ Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc).
▪ Change in mental status.
▪ Death.
Note: additional surgery may be necessary to correct some of these anticipated adverse events.
WARNINGS AND PRECAUTIONS
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other
patient conditions may compromise results. This device system is not intended to be the sole means of spinal support. The
Pyramesh™ Implant System must be used with additional instrumentation to augment stability. Use of this product without a
bone graft may not be successful. No spinal implant can withstand body loads without the support of bone. In this event,
bending, loosening, disassembly, and/or breakage of devices will eventually occur.
Preoperative and operating procedures, including knowledge of surgical techniques, proper selection and placement of
implants, and good reduction are important considerations in the success of surgery. Installation of implants, as well as the
positional adjustment of implants, must only be done with special equipment and instruments specific to these devices. These
devices must only be used with instrumentation specifically recommended by Medtronic. Combination with other instrumentation
may be incompatible and may not be guaranteed.
A device that has been implanted should never be reprocessed or reused under any circumstances. Reuse or reprocessing may
compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient
injury, illness, or death.
Never reuse an internal fixation device under any circumstances. Even when a removed device appears undamaged, it may
have small defects or internal stress patterns that may lead to early breakage. Damage of the thread will reduce stability of
instrumentation.
Further, proper selection and patient compliance will greatly affect results. Patients who smoke were shown to have an
increased incidence of non-unions. These patients should be advised of this possibility and warned of the consequence. Obese,
malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion.
PATIENT INFORMATION
The internal fixation device used in your recent spinal surgery is a metallic implant that attaches to the bone and aids in the
healing of bone grafts. The Pyramesh™ Implant System titanium mesh is intended to replace a vertebral body for tumor and to
replace or restore the height of a vertebral body due to fracture (e.g. burst or compression) to facilitate anterior decompression
of the spinal cord and neural structure, and/or to facilitate the reduction of kyphotic deformities.
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information in this document should be conveyed to the patient.
For US audiences only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
IMPLANT SELECTION
Selection of proper size, shape, and design of the implant for each patient is crucial to success of the procedure. Metallic
surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the size
and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and postoperative
management to minimize stresses on the implant, such stresses may cause metal fatigue and consequent breakage, bending,
or loosening of the device before the healing process is complete, which may result in further injury or the need to remove the
device prematurely.
PREOPERATIVE
▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or predispositions such as those addressed in the contraindications should be avoided.
▪ Care should be used when handling and storing implants. Implants should not be scratched or damaged. Implants and
instruments should be protected during storage, especially from corrosive environments.
▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before using the
equipment and should personally assemble the devices to verify all parts and necessary instruments are present before
surgery.
▪ The type of construct to be assembled for the case should be determined prior to surgery. An adequate inventory of implant
sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used.
▪ Parts should be sterilized before use. Additional sterile components should be available in case of an unexpected need.
INTRAOPERATIVE
Instructions in any available applicable surgical technique manual should be carefully followed.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves will cause loss of
neurological functions.
▪ Breakage, slippage, or misuse of instruments or implants may cause injury to the patient or operative personnel.
▪ To ensure proper fusion below and around the location of the instrumentation, a bone graft should be used. When using the
Pyramesh™ Implant System, grafts containing autogenous or allogenic bone should be used. Bone graft must be placed in
the area to be fused and graft material must extend from the upper vertebrae to the lower vertebrae being fused.
▪ Bone cement should not be used since this material will make removal of the components difficult or impossible. Heat
generated from the curing process may also cause neurologic damage and bone necrosis.
POSTOPERATIVE
The physician's postoperative directions and warnings to the patient and the corresponding patient compliance are extremely
important.
▪ Detailed instructions on use and limitations of the device should be given to the patient. If partial weight bearing is
recommended or required prior to firm bony union, the patient must be warned that bending, loosening or breakage of
devices are complications which can occur as a result of excessive weight bearing or muscular activity. Risk of bending,
loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the
patient is active, debilitated, demented, or otherwise unable to use weight supporting devices. The patient should be
warned to avoid falls or sudden jolts in spinal position.
▪ To allow the maximum chances for a successful surgical result, the patient or device should not be exposed to mechanical
vibrations that may loosen the device construct. The patient should be warned of this possibility and instructed to limit and
restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be
advised not to smoke or consume excess alcohol during the bone graft healing process.
▪ Patients should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this
permanent physical restriction in body motion.
▪ Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. These
stresses can cause eventual bending, loosening, or breakage of the device. It is important that immobilization of the union is
established and confirmed by roentgenographic examination. Where there is a non-union, or if components loosen, bend,
and/or break, the device should be revised and/or removed immediately before serious injury occurs.
▪ Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
When explanting and/or disposing of a device, avoid exposure to bodily substances such as blood, tissue, etc., as contact could
lead to infection or disease. Always wear and use proper equipment, taking special care with sharp objects and needles. Follow
your healthcare center’s policy regarding both the disposal of devices and any events of exposure.
VISUAL INSPECTION
Visually inspect the device before use. If the device is damaged, do not use the product. Contact Medtronic for return
information.
PACKAGING
Devices are provided non-sterile. Packages for devices should be intact upon receipt. If a loaner set is used, all sets and
components should be carefully checked for completeness and to ensure there is no damage prior to use. Damaged packages
or products should not be used and should be returned to Medtronic.
STERILIZATION
Implants used in surgery must be sterilized by the hospital prior to use. Remove all packaging materials prior to sterilization.
Only sterile products should be placed in the operative field. Unless specified elsewhere, these products are recommended to
be steam sterilized by the hospital using one of the sets of the process parameters in Tables 1 or 2.
Table 1: Sterilization cycle parameters for the US and its territories
Method Cycle Temperature Exposure time
Steam Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 275°F (135°C) 3 Minutes 30 Minutes
Note: because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment. It is the user’s responsibility to use only sterilizers and accessories
(e.g. sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes) cleared by
the Food and Drug Administration (FDA) for selected sterilization cycle specifications (time and temperature).
The sterilization cycles listed in Table 2 are not considered by the FDA to be standard sterilization cycles.
*For medical facilities located outside the US and its territories, some non-US health care authorities recommend sterilization
according to these parameters to minimize the risk of transmission of Creutzfeldt-Jakob disease, especially of surgical
instruments that could come into contact with the central nervous system.
Minimum dry time
1
Table 2: Sterilization cycle parameters for medical facilities outside the US and Its territories
Method Cycle Temperature Exposure time
Steam Dynamic-air-removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 20 Minutes 30 Minutes
1
Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient
atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer's recommendations.
Note: because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment.
Minimum dry time
1
MRI INFORMATION
MR Conditional
In non-clinical testing, the Pyramesh™ Implant System was determined to be MR Conditional. A patient with this device can be
safely scanned immediately after device placement under the following conditions:
▪ Static magnetic field of 1.5 and 3 Tesla.
▪ Maximum spatial gradient magnetic field of ≤3000 Gauss/cm (30 T/m).
▪ Maximum whole body average specific absorption rate (SAR) of 1.4 W/kg under normal operating mode for 15 minutes of
scanning per pulse sequence.
Under the scan conditions defined above, the Pyramesh™ Implant System is expected to produce a maximum temperature rise
of <6°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 6mm for a spin echo sequence and 13mm
for a gradient echo sequence in a 3 Tesla MR system. Therefore, optimization of MR imaging parameters to compensate for the
presence of this device may be necessary.
If the Pyramesh™ Implant System is used in connection with any other implant in the body, be advised this combination has not
been tested in the MR environment.
The presence of other implants or the health state of the patient may require a modification of MR conditions.
PRODUCT COMPLAINTS
To report product problems, contact Medtronic.
Patients in the European Union experiencing a serious incident in relation to the device should contact Medtronic and the
competent authority of the Member State in which they are established.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is required, contact Medtronic.
©2020 Medtronic Sofamor Danek USA, Inc. All rights reserved.
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
EXPLANATION OF SYMBOLS
Authorized representative in the European Community
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Do not re-use
Batch code
Manufacturer
Catalogue number
Non-sterile
For US audiences only
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
This device complies with applicable European Union
regulations and directives.
Use-by date
MR Conditional
Consult instructions for use at this website.
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