Study: NCT04980378

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 157 at risk

Adverse event: Infection (not at surgical site)
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 157 at risk

Adverse event: Appendicular arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 157 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 157 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 157 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 157 at risk

Adverse event: Accidental trauma
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 157 at risk

Adverse event: Gastrointestinal complications
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 157 at risk

Adverse event: Cervical radiculopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 157 at risk

Adverse event: Pain (no narcotic given)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 157 at risk

Adverse event: Hematoma or seroma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 157 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 157 at risk

Adverse event: Difficulty with urination
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 157 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 157 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 157 at risk

Adverse event: Blood loss (greater than 500 mL)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 157 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 157 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 157 at risk

Adverse event: Pain (no narcotic given)
Serious: no
Organ System: General disorders
Frequency: 32 affected / 157 at risk

Adverse event: Accidental trauma
Serious: no
Organ System: General disorders
Frequency: 27 affected / 157 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 30 affected / 157 at risk

Adverse event: Cervical radiculopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 157 at risk

Adverse event: Lumbar radiculopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 157 at risk

Adverse event: Appendicular arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 157 at risk

Adverse event: Infection (not at surgical site)
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 157 at risk

Adverse event: Compressive neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 157 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 157 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 157 at risk

Adverse event: Low back pain (no narcotic given)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 157 at risk

Adverse event: Pain (narcotic given)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 157 at risk

Adverse event: Gastrointestinal complications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 157 at risk

Adverse event: Development of DDD at adjacent levels
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Low back pain (narcotic given)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Numbness - increased from pre-op or prior visit
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 157 at risk

Adverse event: Spasm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 157 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 157 at risk

Adverse event: Cardiac event
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 157 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Psychological illness
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 157 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 157 at risk

Adverse event: Dermatitis/Skin allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 157 at risk

Adverse event: Nonunion/pseudoarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 157 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 134 at risk

Adverse event: Infection (not at surgical site)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 134 at risk

Adverse event: Appendicular arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 134 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 134 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 134 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 134 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 134 at risk

Adverse event: Accidental trauma
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 134 at risk

Adverse event: Gastrointestinal complications
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 134 at risk

Adverse event: Cervical radiculopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Pain (no narcotic given)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Difficulty with urination
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 134 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Nonunion/pseudoarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 134 at risk

Adverse event: Psychological illness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 134 at risk

Adverse event: Development of DDD at adjacent levels
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 134 at risk

Adverse event: Surgery at a location other than the spine
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 134 at risk

Adverse event: Cerebrospinal fluid leakage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 134 at risk

Adverse event: Coordination abnormalities
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 134 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 134 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 134 at risk

Adverse event: Surgery at another spine level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 134 at risk

Adverse event: Cardiac event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 134 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 134 at risk

Adverse event: Soft tissue damage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Dermatitis/Skin allergy
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Low back pain (narcotic given)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 134 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 134 at risk

Adverse event: Renal dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 134 at risk

Adverse event: Pain (no narcotic given)
Serious: no
Organ System: General disorders
Frequency: 37 affected / 134 at risk

Adverse event: Accidental trauma
Serious: no
Organ System: General disorders
Frequency: 39 affected / 134 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 29 affected / 134 at risk

Adverse event: Cervical radiculopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 134 at risk

Adverse event: Lumbar radiculopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 28 affected / 134 at risk

Adverse event: Appendicular arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 134 at risk

Adverse event: Infection (not at surgical site)
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 134 at risk

Adverse event: Compressive neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 134 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 23 affected / 134 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 19 affected / 134 at risk

Adverse event: Low back pain (no narcotic given)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 134 at risk

Adverse event: Pain (narcotic given)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 134 at risk

Adverse event: Gastrointestinal complications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 134 at risk

Adverse event: Development of DDD at adjacent levels
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 134 at risk

Adverse event: Low back pain (narcotic given)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 134 at risk

Adverse event: Non-Infectious pulmonary disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 134 at risk

Adverse event: Numbness - increased from pre-op or prior visit
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 134 at risk

Adverse event: Spasm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 134 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 134 at risk

Adverse event: Cardiac event
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 134 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 134 at risk

Adverse event: Psychological illness
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 134 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 134 at risk

Adverse event: Dermatitis/Skin allergy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 134 at risk

Adverse event: Nonunion/pseudoarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 134 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 134 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 134 at risk