TSRH® SPINAL SYSTEM M708348B436E Rev. A
2014-12-22
PURPOSE
The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to
fusion of the thoracic, lumbar, and/or sacral spine.
DESCRIPTION
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates,
and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked
into a variety of configurations, with each construct being tailor-made for the individual case.
A subset of TSRH
constructs may be comprised of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK
connecting components as well as CD HORIZON
Multi-Span
®
implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being
tailored-made for the individual case. All screws used in pediatric cases are only cleared for use via a posterior approach. All of
the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy,
and medical grade cobalt-chromium-molybdenum alloy.
®
TSRH
Spinal System staples, unit rods, s-rods and 7.0mm diameter rods are specifically excluded for use in pediatric patients.
Certain implant components from other Medtronic spinal systems can be used with the TSRH
components. These components include GDLH
screws; DYNALOK
The hooks are intended for posterior use only. The staples are for anterior use only. The TSRH-3D
connectors, and TSRH-3D® and TSRH® 3DxTM screws are intended for posterior use only. Within the TSRH® family, the cobalt
chromium rods should only be used with TSRH
CROSSLINK
The TSRH
®
titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or cobaltchromium-molybdenum alloy may be used together. Certain TSRH
hydroxyapatite. Never use titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy with stainless steel in the
same construct.
No warranties, express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.
To achieve best results, do not use any of the TSRH
system, except those components listed above, or any other manufacturer. As with all orthopaedic and neurosurgical implants,
none of the TSRH
®
Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These
®
Spinal System components cleared for pediatric use such as Low Profile
Crosslink® Plates and CD HORIZON® rods, screws, set screws and locking screws. Similarly to the TSRH
®
®
PLUS bolts, and, VANTAGE™ Anterior Fixation System screws.
®
Axial and Offset Plates may be used anteriorly as well.
rods, rod/bolt connectors, Variable Angle T-bolts, set screws and locking
®
3DxTM Spinal System. All CROSSLINK® Plates are for posterior use and the
®
Plates, plates, and
®
®
Spinal System in non-pediatric
®
and TSRH® 3Dx
TM
Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium or
®
Spinal System components may be coated with
®
Spinal System implant components with components from any other
®
Spinal System components should ever be reused under any circumstances.
INDICATIONS
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft
and/or autograft, the TSRH
degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history
and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4)
dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH
skeletally mature patients using allograft and/or autograft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth
lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having
the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the
development of a solid fusion mass.
®
Spinal System is indicated as an adjunct to fusion for one or more of the following: (1)
®
Spinal System is indicated as an adjunct to fusion for
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the
following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc
confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis,
kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts
at spinal fusion.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH
VANTAGE
stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
For anterior use only the TSRH
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the TSRH
indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TSRH
used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
TM
screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal
®
Spinal System has the additional indication of: spondylolysis.
®
®
Pediatric Spinal System is intended to be
Spinal System implants are
®
L-Plate and
CONTRAINDICATIONS
Contraindications include, but are not limited to:
▪ Active infectious process or significant risk of infection (immunocompromise).
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Grossly distorted anatomy caused by congenital abnormalities.
▪ Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the
presence of 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 not needing a bone graft and fusion.
▪ Any case where the implant components selected for use would be too large or too small to achieve a successful result.
▪ Any case that requires the mixing of metals from two different components or systems.
▪ Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Any patient unwilling to follow postoperative instructions.
▪ Any case not described in the indications.
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 of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of potential adverse events includes, but is not limited to:
▪ Early or late loosening of any or all of the components.
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, and/or general corrosion),
including metallosis, staining, tumor formation, and/or autoimmune disease.
▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing
skin penetration, irritation, fibrosis, necrosis, and/or pain.
▪ Bursitis and tissue or nerve damage caused by improper positioning and placement of implants or instruments.
▪ Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.
▪ Loss of neurological function (e.g., sensory and/or motor), including paralysis (complete or incomplete), dysesthesias,
hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, and/or the development or continuation of pain,
numbness, neuroma, spasms, sensory loss, tingling sensation, and/or visual deficits.
▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,
irritation, arachnoiditis, and/or muscle loss.
▪ Urinary retention or loss of bladder control or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or
vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery.
▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Non-union (or pseudarthrosis), delayed union, and mal-union.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Loss of or increase in spinal mobility or function.
▪ Inability to perform the activities of daily living.
▪ Bone loss or decrease in bone density, possibly caused by stress shielding.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal system compromise.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound
necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise.
▪ 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 potential adverse events.
ADDITIONAL POTENTIAL ADVERSE EVENTS FOR PEDIATRIC PATIENTS
▪ Inability to use pedicle screw fixation due to anatomic limitations (pedicle dimensions, distorted anatomy)
▪ Pedicle screw malpositioning, with or without neurological or vascular injury
▪ Proximal or distal junctional kyphosis
▪ Pancreatitis
WARNINGS
The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant
mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability
or deformity of the thoracic, lumbar, and sacral spine secondary to degenerative spondylolisthesis with objective evidence of
neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The
safety and effectiveness of this device for any other conditions are unknown.
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing,
or resterilization 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.
ADDITIONAL WARNINGS FOR PEDIATRIC PATIENTS
Warning: The safety and effectiveness of this device has not been established for use as part of a growing rod construct. This
device is only intended to be used when definitive fusion is being performed at all instrumented levels.
The use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature
and skeletally immature. Pediatric patients may have smaller spinal structures (pedicle diameter or length) that may preclude
the use of pedicle screws or increase the risk of pedicle screw malpositioning and neurological or vascular injury. Patients not
skeletally mature that undergo spinal fusion procedures may have reduced longitudinal spinal growth, or may be at risk for
rotational spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine.
Other adverse events related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in
pediatric patients. Pediatric patients may be at increased risk for device-related injury because of their smaller stature.
PRECAUTION(S)
The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific
training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of
serious injury to the patient.
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. 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, good reduction, and proper selection and
placement of the implants are important considerations in the successful utilization of the 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.
ADDITIONAL PRECAUTIONS FOR PEDIATRIC PATIENTS
The implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons
with specific training in the use of this pedicle screw spinal system in pediatric patients because this is a technically demanding
procedure presenting a risk of serious injury to the patient.
Loading...