Study: NCT00401518

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 46 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 46 at risk

Adverse event: Urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 46 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 46 at risk

Adverse event: Surgery - Adjacent Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 46 at risk

Adverse event: Pain-Neck and/or Upper Extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pain Lower Extremities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Pain - Hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Surgery - Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 46 at risk

Adverse event: Surgery - Other (Non-Lumbar)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 46 at risk

Adverse event: Surgery - Other Lumbar
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 46 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 46 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 46 at risk

Adverse event: Dysesthesia - Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 20 affected / 46 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 11 affected / 46 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 46 at risk

Adverse event: Dysesthesia - Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Infection - Superficial Wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 46 at risk

Adverse event: Cerebrovascular
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Wound Issue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Pain-Neck and/or Upper Extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 46 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 46 at risk

Adverse event: Pain-Back and Lower Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 46 at risk

Adverse event: Pain Lower Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 46 at risk

Adverse event: Pain - Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 46 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 46 at risk

Adverse event: Neurological Systemic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pain-Back and Lower Extremities with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: Pain Lower Extremities with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 46 at risk

Adverse event: Surgery-Index Level
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 46 at risk

Adverse event: Surgery - Other (Non-Lumbar)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 46 at risk

Adverse event: Paresthesia - Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 46 at risk

Adverse event: Paresthesia - Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 46 at risk

Adverse event: Paresthesia - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Dural tear
Serious: no
Organ System: General disorders
Frequency: 2 affected / 46 at risk

Adverse event: Neurological Focal Lumbar
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 46 at risk

Adverse event: Neurolgical Focal Other
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Radiographic
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 226 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 226 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 226 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 226 at risk

Adverse event: Infection - Deep Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 226 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 226 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 226 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 226 at risk

Adverse event: Urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 226 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 226 at risk

Adverse event: Infection - Superficial Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 226 at risk

Adverse event: Cerebrovascular
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 226 at risk

Adverse event: Surgery - Adjacent Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 226 at risk

Adverse event: Wound Issue
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 226 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 226 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 226 at risk

Adverse event: Pain-Neck and/or Upper Extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 226 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 226 at risk

Adverse event: Pain-Back and Lower Extremities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 226 at risk

Adverse event: Pain Lower Extremities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 226 at risk

Adverse event: Pain - Hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 226 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 226 at risk

Adverse event: Surgery - Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 35 affected / 226 at risk

Adverse event: Surgery - Other (Non-Lumbar)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 226 at risk

Adverse event: Dural tear
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 226 at risk

Adverse event: Neurological Focal Lumbar
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 226 at risk

Adverse event: Radiographic
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 226 at risk

Adverse event: Metal Allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 226 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 226 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 226 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 226 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 226 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 42 affected / 226 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 226 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 226 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 42 affected / 226 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 226 at risk

Adverse event: Dysesthesia - Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 226 at risk

Adverse event: Infection - Superficial Wound
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 226 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 226 at risk

Adverse event: Cerebrovascular
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 226 at risk

Adverse event: Surgery - Adjacent Level
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 226 at risk

Adverse event: Wound Issue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 226 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 226 at risk

Adverse event: Spinous Process Fracture
Serious: no
Organ System: General disorders
Frequency: 1 affected / 226 at risk

Adverse event: Spinal fracture
Serious: no
Organ System: General disorders
Frequency: 2 affected / 226 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 226 at risk

Adverse event: Pain-Neck and/or Upper Extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 226 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 72 affected / 226 at risk

Adverse event: Pain-Back and Lower Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 226 at risk

Adverse event: Pain - Back and Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 226 at risk

Adverse event: Pain Lower Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 68 affected / 226 at risk

Adverse event: Pain - Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 226 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 226 at risk

Adverse event: Neurological Systemic
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 226 at risk

Adverse event: Dysesthesia - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 226 at risk

Adverse event: Pain-Back and Lower Extremities with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 226 at risk

Adverse event: Pain-Back with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 226 at risk

Adverse event: Pain Lower Extremities with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 226 at risk

Adverse event: Surgery-Index Level
Serious: no
Organ System: Surgical and medical procedures
Frequency: 6 affected / 226 at risk

Adverse event: Surgery - Other (Non-Lumbar)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 226 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 226 at risk

Adverse event: Paresthesia - Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 226 at risk

Adverse event: Paresthesia - Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 226 at risk

Adverse event: Surgery - Other Lumbar
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 226 at risk

Adverse event: Dural tear
Serious: no
Organ System: General disorders
Frequency: 22 affected / 226 at risk

Adverse event: Neurological Focal Lumbar
Serious: no
Organ System: Nervous system disorders
Frequency: 104 affected / 226 at risk

Adverse event: Neurolgical Focal Other
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 226 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 226 at risk

Adverse event: Radiographic
Serious: no
Organ System: General disorders
Frequency: 5 affected / 226 at risk

Adverse event: Metal Allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 226 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 117 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 117 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 117 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 117 at risk

Adverse event: Urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 117 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 117 at risk

Adverse event: Cerebrovascular
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 117 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 117 at risk

Adverse event: Pain-Neck and/or Upper Extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 117 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Pain Lower Extremities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 117 at risk

Adverse event: Pain - Hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 117 at risk

Adverse event: Surgery - Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 13 affected / 117 at risk

Adverse event: Surgery - Other Lumbar
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 117 at risk

Adverse event: Dural tear
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 117 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 117 at risk

Adverse event: Dysesthesia - Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 117 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 24 affected / 117 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 2 affected / 117 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 117 at risk

Adverse event: Injury
Serious: no
Organ System: General disorders
Frequency: 26 affected / 117 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 117 at risk

Adverse event: Dysesthesia - Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 117 at risk

Adverse event: Infection - Superficial Wound
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 117 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 117 at risk

Adverse event: Surgery - Adjacent Level
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 117 at risk

Adverse event: Wound Issue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 117 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 117 at risk

Adverse event: Spinal fracture
Serious: no
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Pain-Neck and/or Upper Extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 117 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 117 at risk

Adverse event: Pain-Back and Lower Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 117 at risk

Adverse event: Pain - Back and Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Pain Lower Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 117 at risk

Adverse event: Pain - Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 117 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 117 at risk

Adverse event: Neurological Systemic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Dysesthesia - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Pain-Back and Lower Extremities with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 117 at risk

Adverse event: Pain-Back with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Pain Lower Extremities with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 117 at risk

Adverse event: Surgery-Index Level
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 117 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 117 at risk

Adverse event: Paresthesia - Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 117 at risk

Adverse event: Paresthesia - Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 117 at risk

Adverse event: Pseudoarthrosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 117 at risk

Adverse event: Dural tear
Serious: no
Organ System: General disorders
Frequency: 12 affected / 117 at risk

Adverse event: Neurological Focal Lumbar
Serious: no
Organ System: Nervous system disorders
Frequency: 50 affected / 117 at risk

Adverse event: Neurolgical Focal Other
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 117 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk