Risk and safety information

AVAFlex® curved needle

Indications for Use: The Stryker AVAflex Vertebral Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Potential risks:

  • Embolism of fat, thrombus or other materials resulting in symptomatic pulmonary embolism or other clinical sequelae 
  • Rupture with fragmentation of the balloon resulting in retention of a fragment within the vertebral body 
  • Rupture of the balloon causing contrast medium exposure, possibly resulting in an allergic reaction or anaphylaxis 
  • Radiculopathy, paresis or paralysis 
  • Rupture of the aorta and/or nerve damage 
  • Fracture of the end plate and/or sidewall of the vertebral body due to over inflation of a nonmobile fracture 
  • Pneumothorax 
  • Pedicle fracture

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

AutoPlex® M4 mixer and delivery system

Indications for Use: The Stryker AutoPlex M4 Mixer and Delivery System is used for mixing bone cement and delivering the bone cement percutaneously.

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Bone biopsy kits

Indications for Use: The Stryker iVAS Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique.

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Curette

Indications for Use: The Curette is intended for displacing cancellous bone. This includes use during percutaneous balloon assisted vertebral augmentation. 

Potential risks:

  • Nerve injury, including puncture of the spinal cord or nerve roots, potentially resulting in radiculopathy, paresis, or paralysis 
  • Embolism of fat, thrombus or other materials, resulting in symptomatic pulmonary embolism or other clinical sequelae 
  • Hemothorax or pneumothorax 
  • Unintended puncture wounds, including vascular puncture and dural tear 
  • Bleeding or hemorrhage

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Dekompressor®

Indications for Use: The Dekompressor Percutaneous Discectomy Probe (probe) is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.

Potential risks:

  • Disc space infection 
  • Permanent neurological deficit 
  • Nerve root trauma 
  • Vascular Injury

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

iVAS® Elite balloon system

Indications for Use: The Stryker iVAS Elite Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements and Cortoss® Bone Augmentation Material indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Potential risks:

  • Nerve injury, including puncture of the spinal cord or nerve roots, potentially resulting in radiculopathy, paresis, or paralysis 
  • Embolism of fat, thrombus or other materials, resulting in symptomatic pulmonary embolism or other clinical sequelae 
  • Hemothorax or pneumothorax 
  • Unintended puncture wounds, including vascular puncture and dural tear 
  • Bleeding or hemorrhage

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

mild® system

Indications for Use: The mild Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.

Potential risks:

  • Damage to the nerve roots resulting in numbness, motor weakness, or cauda equina syndrome 
  • Damage to the dural sac causing cerebrospinal fluid leak (CSF) 
  • Damage to epidural vessels causing hematoma 
  • Cerebral spinal fluid leak 
  • Dural tear Sub-acute bleed 
  • Chemical meningitis

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

MultiGen® 2 radiofrequency generator

Indications for Use: The Stryker MultiGen 2 RF Generator, in combination with the Stryker MultiGen 2 Electrodes and RF Cannulae, is intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

OmniCurve® curved balloon system

Indications for Use: The Stryker OmniCurve Vertebral Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Potential risks:

  • Embolism of fat, thrombus or other materials resulting in symptomatic pulmonary embolism or other clinical sequelae 
  • Rupture with fragmentation of the balloon resulting in retention of a fragment within the vertebral body 
  • Rupture of the balloon causing contrast medium exposure, possibly resulting in an allergic reaction or anaphylaxis 
  • Radiculopathy, paresis or paralysis 
  • Rupture of the aorta and/or nerve damage 
  • Fracture of the end plate and/or sidewall of the vertebral body due to over inflation of a nonmobile fracture 
  • Pneumothorax 
  • Pedicle fracture

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

OptaBlate® basivertebral nerve ablation system

Indications for Use: The Stryker OptaBlate BVN Intraosseous Nerve Ablation System is intended for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). 

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

OptaBlate® bone tumor ablation system

Indications for Use: 

  • Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body
  • Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy
  • Ablation of benign bone tumors, such as osteoid osteoma

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

SpineJack® system

Indications for Use: The SpineJack Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures, traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). It is intended to be used in combination with Stryker Vertaplex® and Vertaplex HV bone cement.

Potential risks:

  • The use of the SpineJack system may directly or indirectly cause side effects and complications as presented in, but not limited to, the list below. They are inherent to any percutaneous operation and linked to the injection of PMMA cement in the vertebral body: 
  • Allergies 
  • Thrombosis 
  • Adjacent vertebral fracture 
  • Rib fractures 
  • Intolerance to anesthesia 
  • Cement leaks 
  • Pulmonary embolism 
  • Fall in blood pressure/vagal reactions 
  • Cement intolerance 
  • Neurological complications (organic malfunctions, paraesthesia, radiculopathy, spinal canal or neural foraminal compression) 
  • In addition, refer to the side effects listed in the instructions for use of the PMMA cement used in combination with the SpineJack implant

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

SpinePlex® bone cement

Indications for Use: Indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Potential risks:

  • Cardiac arrest 
  • Myocardial infarction 
  • Pulmonary embolism 
  • Cerebrovascular accident 
  • Anaphylaxis 
  • Hypertension 
  • Hypotension 
  • Nerve entrapment 
  • Transitory fall in blood pressure 
  • Thrombophlebitis 
  • Hemorrhage and hematoma 
  • Trochanteric bursitis 
  • Trochanteric separation 
  • Heterotopic new bone 
  • Short term irregularities in cardiac conduction 
  • Pyrexia 
  • Hematuria 
  • Bladder fistula

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

VertaPlex® bone cement

Indications for Use: VertaPlex Radiopaque Bone Cement is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with the SpineJack System, VertaPlex Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures.

Potential risks:

  • Cardiac arrest 
  • Myocardial infarction 
  • Pulmonary embolism
  • Cardiac embolism 
  • Cerebrovascular accident 
  • Anaphylaxis 
  • Hypertension 
  • Hypotension 
  • Nerve entrapment 
  • Nerve damage 
  • Transitory fall in blood pressure 
  • Thrombophlebitis 
  • Hemorrhage 
  • Trochanteric bursitis 
  • Trochanteric separation 
  • Loosening or displacement of the prosthesis 
  • Heterotopic new bone 
  • Short term irregularities in cardiac conduction 
  • Pyrexia Hematuria

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

VertaPlex® HV bone cement

Indications for Use: VertaPlex High Viscosity (HV) Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma). When used in conjunction with ES2® Augmentable Spinal System, VertaPlex HV Radiopaque Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Vertaplex HV Radiopaque Bone Cement and the ES2 Augmentable Spinal System are for use together at spinal levels where the structural integrity of the spine is not severely compromised.

U.S. additional indications: When used in conjunction with the SpineJack system, VertaPlex HV Radiopaque Bone Cement is also indicated for the fixation of osteoporotic or traumatic AO/Magerl Type A vertebral compression fractures.

Potential risks:

  • Cardiac arrest 
  • Myocardial infarction 
  • Pulmonary embolism 
  • Cardiac embolism 
  • Cerebrovascular accident 
  • Anaphylaxis 
  • Hypertension 
  • Hypotension 
  • Nerve entrapment 
  • Nerve damage 
  • Transitory fall in blood pressure 
  • Thrombophlebitis 
  • Hemorrhage 
  • Trochanteric bursitis 
  • Trochanteric separation 
  • Loosening or displacement of the prosthesis 
  • Heterotopic new bone 
  • Short term irregularities in cardiac conduction 
  • Pyrexia 
  • Hematuria

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Verteport® cement cannula

Indications for Use: Stryker VertePort Cement Cannulas and Access Cannulas are used to provide and maintain access to the vertebral body for the injection of bone cement/ augmentation material.

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Verteport X4 manifold® cement delivery assistant

Indications for Use: Serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism and cardiac embolism. Although it is rare, some adverse events have been known to occur up to one year post-operatively. Additional risks exist with the use of bone cement.

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Venom® cannula and electrode system

Indications for Use: The Stryker Venom MultiGen 2 Electrodes, in combination with the Stryker RF Cannulae and Stryker MultiGen 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

Please see the Instructions for Use for a complete list of warnings, precautions and adverse events prior to using the device.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.