Study: NCT00295009

Adverse event: Additional Surgery Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 80 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 80 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 80 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 80 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 80 at risk

Adverse event: Surgery - Adjacent Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 80 at risk

Adverse event: Surgery - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 80 at risk

Adverse event: Additional Surgery Index Level
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 80 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 80 at risk

Adverse event: Burning or Dysesthetic Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 80 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 80 at risk

Adverse event: Degenerative Disease Progression
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Degenerative Disease Progression, Other Lumbar
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 80 at risk

Adverse event: Dermatological or Drug Allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 80 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 80 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 80 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 80 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 6 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 80 at risk

Adverse event: Incision Site Related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 80 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 80 at risk

Adverse event: Infection - Other non-wound related
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 80 at risk

Adverse event: Infection - Superficial Wound with Incision Site Pain
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Infection, Not Index Level Related
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 80 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Migration Not Requiring Surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 80 at risk

Adverse event: Muscoloskeletal Spasms - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 80 at risk

Adverse event: Musculoskeletal Spasms - Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Musculoskeletal Spasm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 80 at risk

Adverse event: Neurological
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 80 at risk

Adverse event: Non-Specific Musculoskeletal Spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 80 at risk

Adverse event: Numbness Peripheral Nerve or Non-Index Level Related
Serious: no
Organ System: General disorders
Frequency: 9 affected / 80 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 80 at risk

Adverse event: Other Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 80 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 34 affected / 80 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 22 affected / 80 at risk

Adverse event: Pain - Back and Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Pain - Back and Other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 80 at risk

Adverse event: Pain - Incision Site
Serious: no
Organ System: General disorders
Frequency: 6 affected / 80 at risk

Adverse event: Pain - Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 20 affected / 80 at risk

Adverse event: Pain - Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 2 affected / 80 at risk

Adverse event: Pain Other (Not back, hip, leg)
Serious: no
Organ System: General disorders
Frequency: 17 affected / 80 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 80 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 80 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Surgery - Index Level (Revision)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 80 at risk

Adverse event: Surgery - Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 80 at risk

Adverse event: Vascular injury
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 80 at risk

Adverse event: Vessel Damage/Bleeding, Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 80 at risk

Adverse event: Wound Issues - Other
Serious: no
Organ System: General disorders
Frequency: 9 affected / 80 at risk

Adverse event: Additional Surgery Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 162 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 162 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 162 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 162 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 162 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 162 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 162 at risk

Adverse event: Surgery - Adjacent Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 162 at risk

Adverse event: Surgery - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 20 affected / 162 at risk

Adverse event: Additional Surgery Index Level
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 162 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 162 at risk

Adverse event: Burning or Dysesthetic Pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 162 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 162 at risk

Adverse event: Degenerative Disease Progression
Serious: no
Organ System: General disorders
Frequency: 17 affected / 162 at risk

Adverse event: Degenerative Disease Progression, Other Lumbar
Serious: no
Organ System: General disorders
Frequency: 11 affected / 162 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 162 at risk

Adverse event: Dermatological or Drug Allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 162 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 162 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 162 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 162 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 162 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 19 affected / 162 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 162 at risk

Adverse event: Incision Site Related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 162 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 162 at risk

Adverse event: Infection - Other non-wound related
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 162 at risk

Adverse event: Infection, Not Index Level Related
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 162 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 162 at risk

Adverse event: Migration Not Requiring Surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 162 at risk

Adverse event: Muscoloskeletal Spasms - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 162 at risk

Adverse event: Musculoskeletal Spasms - Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 162 at risk

Adverse event: Musculoskeletal Spasm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 162 at risk

Adverse event: Neurological
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 162 at risk

Adverse event: Non-Specific Musculoskeletal Spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 162 at risk

Adverse event: Numbness Peripheral Nerve or Non-Index Level Related
Serious: no
Organ System: General disorders
Frequency: 27 affected / 162 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 20 affected / 162 at risk

Adverse event: Other Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 162 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 85 affected / 162 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 44 affected / 162 at risk

Adverse event: Pain - Back and Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 7 affected / 162 at risk

Adverse event: Pain - Back and Other
Serious: no
Organ System: General disorders
Frequency: 9 affected / 162 at risk

Adverse event: Pain - Incision Site
Serious: no
Organ System: General disorders
Frequency: 4 affected / 162 at risk

Adverse event: Pain - Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 51 affected / 162 at risk

Adverse event: Pain - Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 6 affected / 162 at risk

Adverse event: Pain Other (Not back, hip, leg)
Serious: no
Organ System: General disorders
Frequency: 46 affected / 162 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 162 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 162 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 162 at risk

Adverse event: Surgery - Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 162 at risk

Adverse event: Vascular injury
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 162 at risk

Adverse event: Vessel Damage/Bleeding, Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 162 at risk

Adverse event: Wound Issues - Other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 162 at risk

Adverse event: Additional Surgery Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 50 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 50 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 50 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 50 at risk

Adverse event: Surgery - Adjacent Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 50 at risk

Adverse event: Surgery - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 50 at risk

Adverse event: Burning or Dysesthetic Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 50 at risk

Adverse event: Degenerative Disease Progression
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Degenerative Disease Progression, Other Lumbar
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Dermatological or Drug Allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 50 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 4 affected / 50 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 50 at risk

Adverse event: Incision Site Related
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Infection - Other non-wound related
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 50 at risk

Adverse event: Infection - Superficial Wound with Incision Site Pain
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Infection, Not Index Level Related
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 50 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Migration Not Requiring Surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 50 at risk

Adverse event: Muscoloskeletal Spasms - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Musculoskeletal Spasm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 50 at risk

Adverse event: Neurological
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 50 at risk

Adverse event: Numbness Peripheral Nerve or Non-Index Level Related
Serious: no
Organ System: General disorders
Frequency: 6 affected / 50 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 50 at risk

Adverse event: Other Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 50 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 23 affected / 50 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 17 affected / 50 at risk

Adverse event: Pain - Back and Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Pain - Back and Other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 50 at risk

Adverse event: Pain - Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 17 affected / 50 at risk

Adverse event: Pain - Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 2 affected / 50 at risk

Adverse event: Pain Other (Not back, hip, leg)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 50 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 50 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Surgery - Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 4 affected / 50 at risk

Adverse event: Wound Issues - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Additional Surgery Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 72 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 72 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 72 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 72 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 72 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 72 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 72 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 72 at risk

Adverse event: Surgery - Adjacent Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 72 at risk

Adverse event: Surgery - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 72 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 72 at risk

Adverse event: Burning or Dysesthetic Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 72 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 72 at risk

Adverse event: Degenerative Disease Progression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 72 at risk

Adverse event: Degenerative Disease Progression, Other Lumbar
Serious: no
Organ System: General disorders
Frequency: 7 affected / 72 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 72 at risk

Adverse event: Dermatological or Drug Allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 72 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 72 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 72 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 72 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 72 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 9 affected / 72 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 10 affected / 72 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 72 at risk

Adverse event: Infection - Other non-wound related
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 72 at risk

Adverse event: Infection - Superficial Wound with Incision Site Pain
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 72 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 72 at risk

Adverse event: Muscoloskeletal Spasms - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 72 at risk

Adverse event: Musculoskeletal Spasms - Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 72 at risk

Adverse event: Neurological
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 72 at risk

Adverse event: Non-Specific Musculoskeletal Spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 72 at risk

Adverse event: Numbness Peripheral Nerve or Non-Index Level Related
Serious: no
Organ System: General disorders
Frequency: 15 affected / 72 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 13 affected / 72 at risk

Adverse event: Other Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 72 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 42 affected / 72 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 23 affected / 72 at risk

Adverse event: Pain - Back and Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 3 affected / 72 at risk

Adverse event: Pain - Back and Other
Serious: no
Organ System: General disorders
Frequency: 5 affected / 72 at risk

Adverse event: Pain - Incision Site
Serious: no
Organ System: General disorders
Frequency: 8 affected / 72 at risk

Adverse event: Pain - Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 30 affected / 72 at risk

Adverse event: Pain - Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 6 affected / 72 at risk

Adverse event: Pain Other (Not back, hip, leg)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 72 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 72 at risk

Adverse event: Pseudoarthrosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 72 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 72 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 72 at risk

Adverse event: Surgery - Index Level (Revision)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 72 at risk

Adverse event: Surgery - Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 72 at risk

Adverse event: Wound Issues - Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 72 at risk

Adverse event: Additional Surgery Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 165 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 165 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 165 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 165 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 165 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 165 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 165 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 165 at risk

Adverse event: Surgery - Adjacent Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 165 at risk

Adverse event: Surgery - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 19 affected / 165 at risk

Adverse event: Additional Surgery Index Level
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 165 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 165 at risk

Adverse event: Burning or Dysesthetic Pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 165 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 165 at risk

Adverse event: Degenerative Disease Progression
Serious: no
Organ System: General disorders
Frequency: 7 affected / 165 at risk

Adverse event: Degenerative Disease Progression, Other Lumbar
Serious: no
Organ System: General disorders
Frequency: 6 affected / 165 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 165 at risk

Adverse event: Dermatological or Drug Allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 165 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 165 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 165 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 31 affected / 165 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 165 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 25 affected / 165 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 15 affected / 165 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 165 at risk

Adverse event: Infection - Other non-wound related
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 165 at risk

Adverse event: Infection - Superficial Wound with Incision Site Pain
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 165 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 165 at risk

Adverse event: Migration Not Requiring Surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 165 at risk

Adverse event: Muscoloskeletal Spasms - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 165 at risk

Adverse event: Musculoskeletal Spasms - Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 165 at risk

Adverse event: Neurological
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 165 at risk

Adverse event: Non-Specific Musculoskeletal Spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 165 at risk

Adverse event: Numbness Peripheral Nerve or Non-Index Level Related
Serious: no
Organ System: General disorders
Frequency: 30 affected / 165 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 27 affected / 165 at risk

Adverse event: Other Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 165 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 67 affected / 165 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 46 affected / 165 at risk

Adverse event: Pain - Back and Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 8 affected / 165 at risk

Adverse event: Pain - Back and Other
Serious: no
Organ System: General disorders
Frequency: 15 affected / 165 at risk

Adverse event: Pain - Incision Site
Serious: no
Organ System: General disorders
Frequency: 19 affected / 165 at risk

Adverse event: Pain - Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 61 affected / 165 at risk

Adverse event: Pain - Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 8 affected / 165 at risk

Adverse event: Pain Other (Not back, hip, leg)
Serious: no
Organ System: General disorders
Frequency: 32 affected / 165 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 165 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 31 affected / 165 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 165 at risk

Adverse event: Surgery - Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 34 affected / 165 at risk

Adverse event: Vessel Damage/Bleeding, Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 165 at risk

Adverse event: Wound Issues - Other
Serious: no
Organ System: General disorders
Frequency: 15 affected / 165 at risk

Adverse event: Additional Surgery Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 259 at risk

Adverse event: Blood Loss
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 259 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 259 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 259 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 259 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 259 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 259 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 259 at risk

Adverse event: Surgery - Adjacent Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 259 at risk

Adverse event: Surgery - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 18 affected / 259 at risk

Adverse event: Additional Surgery Index Level
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 259 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 259 at risk

Adverse event: Burning or Dysesthetic Pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 259 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 259 at risk

Adverse event: Degenerative Disease Progression
Serious: no
Organ System: General disorders
Frequency: 3 affected / 259 at risk

Adverse event: Degenerative Disease Progression, Other Lumbar
Serious: no
Organ System: General disorders
Frequency: 7 affected / 259 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 259 at risk

Adverse event: Dermatological or Drug Allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 259 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 259 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 259 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 259 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 81 affected / 259 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 31 affected / 259 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 24 affected / 259 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 259 at risk

Adverse event: Infection - Other non-wound related
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 259 at risk

Adverse event: Infection - Superficial Wound with Incision Site Pain
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 259 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 33 affected / 259 at risk

Adverse event: Migration Not Requiring Surgery
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 259 at risk

Adverse event: Muscoloskeletal Spasms - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 259 at risk

Adverse event: Musculoskeletal Spasms - Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 259 at risk

Adverse event: Neurological
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 259 at risk

Adverse event: Non-Specific Musculoskeletal Spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 259 at risk

Adverse event: Numbness Peripheral Nerve or Non-Index Level Related
Serious: no
Organ System: General disorders
Frequency: 44 affected / 259 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 23 affected / 259 at risk

Adverse event: Other Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 259 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 84 affected / 259 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 43 affected / 259 at risk

Adverse event: Pain - Back and Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 7 affected / 259 at risk

Adverse event: Pain - Back and Other
Serious: no
Organ System: General disorders
Frequency: 22 affected / 259 at risk

Adverse event: Pain - Incision Site
Serious: no
Organ System: General disorders
Frequency: 21 affected / 259 at risk

Adverse event: Pain - Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 85 affected / 259 at risk

Adverse event: Pain - Lower Extremities with Numbness at Index Level
Serious: no
Organ System: General disorders
Frequency: 15 affected / 259 at risk

Adverse event: Pain Other (Not back, hip, leg)
Serious: no
Organ System: General disorders
Frequency: 37 affected / 259 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 259 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 259 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 259 at risk

Adverse event: Surgery - Index Level (Revision)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 259 at risk

Adverse event: Surgery - Other
Serious: no
Organ System: Surgical and medical procedures
Frequency: 27 affected / 259 at risk

Adverse event: Vessel Damage/Bleeding, Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 259 at risk

Adverse event: Wound Issues - Other
Serious: no
Organ System: General disorders
Frequency: 23 affected / 259 at risk