Medtronic X1210064 Instructions for Use

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.