PYRAMID™ +4 Anterior Lumbar Plate
M708348B619E Rev. A
System
2017-10-06
IMPORTANT INFORMATION ON THE PYRAMID™ +4 ANTERIOR LUMBAR PLATE
SYSTEM
PURPOSE
The PYRAMID™ +4 Anterior Lumbar Plate System is a temporary implantable device used for the correction and stabilization of
the spine, as well as to help augment the development of a solid spinal fusion.
DESCRIPTION
The PYRAMID™ +4 Anterior Lumbar Plate System is a supplemental fixation device consisting of a variety of shapes and sizes
of plates, and screws, as well as ancillary products and instrument sets. The PYRAMID™ +4 Anterior Lumbar Plate System
components can be locked into a variety of configurations, with each construct being tailor-made for the individual case.
As with all orthopedic and neurosurgical implants, none of the PYRAMID™ +4 Anterior Lumbar Plate Fixation System
components should ever be reused under any circumstances.
The PYRAMID™ +4 Anterior Lumbar Plate System implant components are made of titanium alloy. Stainless steel and titanium
implant components must not be used together in a construct. Medtronic expressly warrants that these devices are fabricated
from the foregoing material specification. No other warranties, express or implied, are made. Implied warranties of
merchantability and fitness for a particular purpose or use are specifically excluded.
INDICATIONS
The Medtronic Spinal and Biologics PYRAMID™ +4 Anterior Lumbar Plate Fixation System is indicated for use as a
supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or
anterior lateral above the bifurcation (L1-L5) of the vascular structures. When properly used, this system will help provide
temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (DDD - as
defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2)
pseudoarthrosis; 3) spondylolysis; 4) spondylolisthesis; 5)fracture; 6) neoplastic disease; 7) unsuccessful previous fusion
surgery; 8) lordotic deformities of the spine; 9) idiopathic thoracolumbar or lumbar scoliosis; 10) deformity (i.e. scoliosis,
lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or
myelomeningocele; and/or 11) neuromuscular deformity (i.e. scoliosis, lordosis, and/or kyphosis) associated with pelvic
obliquity.
CONTRAINDICATIONS
Contraindications include:
▪ Infection local to the operative site.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Any medical or surgical condition 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.
▪ Suspected or documented metal allergy or intolerance.
▪ Any case needing to mix metals from different components.
▪ Any case not needing a bone graft and fusion or requiring fracture healing.
▪ Any patient having inadequate tissue coverage over the operative site, or inadequate bone stock or bone quality such as in
the sacrum.
▪ Any time implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Any patient who will not follow postoperative instructions, such as drug/alcohol abuse patients, and are unwilling to restrict
postoperative activities.
▪ Any case not described in the indications.
▪ Any patient unwilling to follow the postoperative instructions.
Contraindications of this device are consistent with those of other anterior spinal instrumentation systems. This spinal implant
system is not designed, intended, or sold for uses other than those indicated.
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.
POSSIBLE ADVERSE EFFECTS
▪ Early or late loosening of the components.
▪ Implant migration.
▪ Disassembly, bending, loosening, slippage, and/or breakage of any or all of the components or instruments.
▪ Foreign body reaction to the implants including possible tumor formation, autoimmune disease, metallosis, and/or scarring.
▪ Pressure on the skin possibly resulting in skin breakdown from component parts where there is inadequate tissue coverage
over the implant. Implant or graft extrusion through the skin. Wound complications.
▪ Loss of proper spinal curvature, correction, height, and/or reduction.
▪ Infection.
▪ Bone fracture or stress shielding at, above, or below the level of surgery.
▪ Non-union (or pseudoarthrosis).
▪ Loss of neurological function, appearance of radiculopathy, dural tears, and/or development of pain. Neurovascular
compromise including paralysis or other types of serious injury. Cerebral spine fluid leakage.
▪ Gastrointestinal, urological, and/or reproductive system compromise, including sterility, impotency, and/or loss of
consortium.
▪ Hemorrhage of blood vessels and/or hematomas.
▪ Discitis, arachnoiditis, and/or other types of inflammation.
▪ Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus.
▪ Bone graft donor site pain.
▪ Inability to resume activities of normal daily living.
▪ Death.
Note: additional surgery may be necessary to correct some of these anticipated adverse reactions.
WARNINGS AND PRECAUTIONS
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many
extenuating circumstances may compromise the results. The PYRAMID™ +4 Anterior Lumbar Plate System components are
only temporary implants used for the correction and stabilization of the spine. This system is also intended to be used to
augment the development of a spinal fusion by providing temporary stabilization. This device system is not intended to be the
sole means of spinal support. Use of this product without a bone graft or in cases that develop into a non-union will 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 the device(s) will eventually occur.
Preoperative and operating procedures, including knowledge of surgical techniques, proper reduction, and proper selection and
placement of the implant are important considerations in the successful utilization of the PYRAMID™ +4 Anterior Lumbar Plate
System by the surgeon. Further, the proper selection and compliance of the patient will greatly affect the results. Patients who
smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and
warned of this consequence. Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion.
Patients with poor muscle and bone quality and/or nerve paralysis are also poor candidates for spine fusion. The use of allograft
material may not give as good a result as pure autograft.
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information given in this document should be conveyed to the patient.
Caution: for use on or by the order of a physician only.
For US Audiences Only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
IMPLANT SELECTION
The selection of the proper size, shape, and design of the implant for each patient is crucial to the 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 predisposition such as those addressed in the aforementioned contraindications should be
avoided.
▪ Care should be used in the handling and storage of the implant components. The implants should not be scratched or
damaged. Implants and instruments should be protected during storage especially from corrosive environments.
▪ The type of construct to be assembled for the case should be determined prior to beginning the surgery.
▪ 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. PYRAMID™ +4 system components are not to be combined with the components from another manufacturer.
Different metal types should not be used together.
▪ Unless sterile packaged, all parts should be cleaned and sterilized before use. Additional sterile components should be
available in case of an unexpected need.
INTRAOPERATIVE
▪ Any instruction manuals should be carefully followed.
▪ When the configuration of the bone cannot be fitted with an available temporary internal fixation device, and contouring is
absolutely necessary, it is recommended that such contouring is gradual and great care is used to avoid notching or
scratching the surface of the device(s). The components should not be repeatedly or excessively bent any more than
absolutely necessary. The components should not be reverse bent in the same location.
▪ The implant surfaces should not be scratched or notched, since such actions may reduce the functional strength of the
construct.
▪ To ensure proper fusion below and around the location of the instrumentation, a bone graft should be used.
▪ Bone cement should not be used since this material will make removal of the components difficult or impossible. The heat
generated from the curing process may also cause neurologic damage and bone necrosis.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss
of neurological functions.
▪ Before closing, all of the screws should be seated onto the plate. Caution: do not over tighten so as to prevent stripping of
the threads.
POSTOPERATIVE
The physician’s postoperative directions and warnings to the patient and the corresponding patient compliance are extremely
important.
▪ Detailed instructions on the 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 the
device are complications which can occur as a result of excessive weight bearing or muscular activity. The risk of bending,
loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the
patient is active, or if the patient is debilitated, demented or otherwise unable to use crutches or other 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 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.
▪ If a non-union develops or if the components loosen, bend, and/or break, the device(s) should be revised and/or removed
immediately before serious injury occurs. Failure to immobilize a delayed or non-union of bone will result in excessive and
repeated stresses on the implant. By the mechanism of fatigue these stresses can cause eventual bending, loosening, or
breakage of the device(s). It is important that immobilization of the fracture or surgical site be maintained until firm bony
union is established and confirmed by roentgenographic examination. The patient must be adequately warned of these
hazards and closely supervised to ensure cooperation until bony union is achieved.
▪ PYRAMID™ +4 Anterior Lumbar Plate System implants are temporary internal fixation devices. Internal fixation devices are
designed to stabilize the operative site during the normal healing process. After healing occurs, these devices serve no
functional purpose and must be removed. In most cases, removal is indicated because the implants are not intended to
transfer or support forces developed during normal activities. If the device is not removed following completion of its
intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain, (2)
Migration of implant position resulting in injury, (3) Risk of additional injury from postoperative trauma, (4) Bending,
loosening and/or breakage, which could make removal impractical or difficult, (5) Pain, discomfort, or abnormal sensations
due to the presence of the device, (6) Possible increased risk of infection, and 7) Bone loss due to stress shielding. Implant
removal, should be followed by adequate postoperative management to avoid fracture or re-fracture.
▪ Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with
all orthopedic implants, none of the PYRAMID™ +4 Anterior Lumbar Plate System components should ever be reused
under any circumstances.
A device that has been implanted should never be reused, reprocessed or resterilized under any circumstances. Sterile
packaged devices should also never be resterilized. Reuse, reprocessing, or resterilization may compromise the structural
integrity of these implants and create a risk of contamination of the implants which could result in patient injury, illness, or death.
PACKAGING
If devices are individually packaged, packages for each of the components should be intact upon receipt. If a loaner or
consignment system is used, all sets should be carefully checked for completeness and all components should be carefully
checked for damage prior to use. Damaged packages or products should not be used, and should be returned to Medtronic.
STERILIZATION
Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all 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 process parameters in Table 1.
Table 1: Sterilization cycle parameters for the US and its territories
Method Cycle Temperature Exposure time
Minimum dry 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.
*For medical facilities located outside the US and its territories. Some non-US health care authorities recommend sterilization
according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of
surgical instruments that could come into contact with the central nervous system.
Table 2: Sterilization cycle parameters for medical facilities outside the US and its territories
Method Cycle Temperature Exposure time
Minimum dry 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
1
1
The 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.
MRI INFORMATION
The PYRAMID™ +4 Anterior Lumbar Plate System 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 PYRAMID™ +4 Anterior
Lumbar Plate System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
PRODUCT COMPLAINTS
For product problems, contact Medtronic.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is needed or required, contact Medtronic.
©2017 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
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
The device complies with European Directive MDD
93/42/EEC
Do not re-use
Batch code
Manufacturer
Catalogue number
For US audiences only
Use-by date
Non-sterile
Consult instructions for use at this website.
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