Study: NCT00692276

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 190 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 190 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 190 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 190 at risk

Adverse event: Cerebrovascular Accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 190 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 190 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 190 at risk

Adverse event: Dural Leak
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 190 at risk

Adverse event: Gastrointestional Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 190 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 190 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 190 at risk

Adverse event: Neurological Disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 190 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: Other Adverse Events include events not fitting an existing adverse event category, including insomnia, psychological disorder, weight loss, general weakness, ganglion cysts, and drug withdrawal
Frequency: 37 affected / 190 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 190 at risk

Adverse event: Pain - Buttock or Groin
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 190 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 190 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 190 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 190 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 190 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 190 at risk

Adverse event: Spinal Stenosis Symptoms at Index Level
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 190 at risk

Adverse event: Spinous Process Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 190 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 190 at risk

Adverse event: Wound drainage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 190 at risk

Adverse event: Chronic obstructive pulmonary disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 190 at risk

Adverse event: Injury, accidental
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 190 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 190 at risk

Adverse event: Adjacent level degenerative disk disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 190 at risk

Adverse event: Cancer/neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 190 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 190 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 190 at risk

Adverse event: Device subsidence
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 190 at risk

Adverse event: Genitiurinary
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 190 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 190 at risk

Adverse event: Pain - buttock
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 190 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 190 at risk

Adverse event: Cancer/Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 190 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 190 at risk

Adverse event: Endocrine/Metabolic
Serious: no
Organ System: Endocrine disorders
Frequency: 11 affected / 190 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 22 affected / 190 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 190 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 78 affected / 190 at risk

Adverse event: Neurological Disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 190 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: Other Adverse Events including events not fitting a specific adverse event category, including insomnia, psychological disorder, weight loss, general weakness, ganglion cysts, and drug withdrawal
Frequency: 14 affected / 190 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 190 at risk

Adverse event: Pain - Buttock and Groin
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 190 at risk

Adverse event: Pain - Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 190 at risk

Adverse event: Spinal Stenosis at Index Level
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 190 at risk

Adverse event: Spinal Process Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 190 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 201 at risk

Adverse event: Cerebrovascular Accident (CVA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 201 at risk

Adverse event: Coronary Episode, Ischemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 201 at risk

Adverse event: Deep Infection at the Operative Site
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 201 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 201 at risk

Adverse event: Dural Leak
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 201 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 201 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 201 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 201 at risk

Adverse event: Gastrointestional Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 201 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 201 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 201 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 201 at risk

Adverse event: Neurological Disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 201 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: Other Adverse Events include events not fitting an existing adverse event category, including insomnia, psychological disorder, weight loss, general weakness, ganglion cysts, and drug withdrawal
Frequency: 30 affected / 201 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 201 at risk

Adverse event: Pain - Buttock or Groin
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 201 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 201 at risk

Adverse event: Presence of Osteophyte Formation associated with Severe Disc or Facet Degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 201 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 201 at risk

Adverse event: Respiratory disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 201 at risk

Adverse event: Soft Tissue Damage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 201 at risk

Adverse event: Spinal Stenosis Symptoms at Index Level
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 201 at risk

Adverse event: Spinous Process Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 201 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 201 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 201 at risk

Adverse event: Vertebral Compression Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 201 at risk

Adverse event: Wound Dehiscence or Delayed Healing
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 201 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 201 at risk

Adverse event: Injury, accidental
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 201 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 201 at risk

Adverse event: Loss of bowel control
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 201 at risk

Adverse event: Adjacent level stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 201 at risk

Adverse event: Cancer/neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 201 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 201 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 201 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 201 at risk

Adverse event: Genitiurinary
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 201 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 201 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 201 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 201 at risk

Adverse event: Sensory loss
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 201 at risk

Adverse event: Cancer/Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 13 affected / 201 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 201 at risk

Adverse event: Endocrine/Metabolic
Serious: no
Organ System: Endocrine disorders
Frequency: 11 affected / 201 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 17 affected / 201 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 201 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 70 affected / 201 at risk

Adverse event: Neurological Disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 201 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: Other Adverse Events including events not fitting a specific adverse event category, including insomnia, psychological disorder, weight loss, general weakness, ganglion cysts, and drug withdrawal
Frequency: 5 affected / 201 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 201 at risk

Adverse event: Pain - Buttock and Groin
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 201 at risk

Adverse event: Pain - Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 47 affected / 201 at risk

Adverse event: Spinal Stenosis at Index Level
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 201 at risk

Adverse event: Spinal Process Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 201 at risk