Medtronic 905-101 Instructions for Use

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.