Study: NCT02700451

Adverse event: Cardiopulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypotension tachycardia hypertension DVT hypoxia palpitations other pulmonary arrhythmia bradycardia pulmonary embolism other cardiopulmonary chest pain cough pleural effusion
Frequency: 1 affected / 44 at risk

Adverse event: Implant-related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 44 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: leg pain gout back pain knee pain hip pain hand pain neck pain arthritis foot pain fracture carpal tunnel shoulder pain low back pain
Frequency: 6 affected / 44 at risk

Adverse event: Neurologic
Serious: yes
Organ System: Nervous system disorders
Notes: Radiculopathy Sensory deficit motor deficit/weakness cervical radiculopathy spasm mental status change Radiculopathy cervical Sensory deficit
Frequency: 3 affected / 44 at risk

Adverse event: Radiographic
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: adjacent segment degeneration pseudarthrosis
Frequency: 2 affected / 44 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: ABLA, Fever, lightheaded/dizzy, pruritis, headache, adhesive reaction, rash, cancer, trigger finger, sore throat, dermatological, tear in the throat, elevated liver enzymes, sinusitis, transaminitis, rhinitis, hearing, bone quality, hyperglycemia
Frequency: 1 affected / 44 at risk

Adverse event: cardiopulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypotension tachycardia hypertension DVT hypoxia palpitations other pulmonary arrhythmia bradycardia pulmonary embolism other cardiopulmonary chest pain cough pleural effusion
Frequency: 10 affected / 44 at risk

Adverse event: fall (mechanical)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: fall (syncope)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea nausea/vomiting distention constipation ileus diarrhea other gastrointestinal pain abdominal pain
Frequency: 15 affected / 44 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: UTI Superficial infection deep infection
Frequency: 4 affected / 44 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: leg pain gout back pain knee pain hip pain hand pain neck pain arthritis foot pain fracture carpal tunnel shoulder pain low back pain
Frequency: 13 affected / 44 at risk

Adverse event: neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Radiculopathy Sensory deficit motor deficit/weakness cervical radiculopathy spasm mental status change Radiculopathy cervical Sensory deficit
Frequency: 26 affected / 44 at risk

Adverse event: operative
Serious: no
Organ System: Surgical and medical procedures
Notes: Dural Tear Monitoring anomaly (SSEP) Monitoring Anomaly vascular injury
Frequency: 1 affected / 44 at risk

Adverse event: renal
Serious: no
Organ System: Renal and urinary disorders
Notes: oliguria urinary retention hematuria Electrolyte imbalance Other
Frequency: 4 affected / 44 at risk

Adverse event: Wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: prolonged drainage seroma swelling redness pain
Frequency: 9 affected / 44 at risk

Adverse event: other
Serious: no
Organ System: General disorders
Notes: ABLA, Fever, lightheaded/dizzy, pruritis, headache, adhesive reaction, rash, cancer, trigger finger, sore throat, dermatological, tear in the throat, elevated liver enzymes, sinusitis, transaminitis, rhinitis, hearing, bone quality, hyperglycemia
Frequency: 23 affected / 44 at risk

Adverse event: Implant-related
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 43 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: UTI Superficial infection deep infection
Frequency: 2 affected / 43 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: leg pain gout back pain knee pain hip pain hand pain neck pain arthritis foot pain fracture carpal tunnel shoulder pain low back pain
Frequency: 2 affected / 43 at risk

Adverse event: Neurologic
Serious: yes
Organ System: Nervous system disorders
Notes: Radiculopathy Sensory deficit motor deficit/weakness cervical radiculopathy spasm mental status change Radiculopathy cervical Sensory deficit
Frequency: 5 affected / 43 at risk

Adverse event: Radiographic
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: adjacent segment degeneration pseudarthrosis
Frequency: 2 affected / 43 at risk

Adverse event: cardiopulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypotension tachycardia hypertension DVT hypoxia palpitations other pulmonary arrhythmia bradycardia pulmonary embolism other cardiopulmonary chest pain cough pleural effusion
Frequency: 7 affected / 43 at risk

Adverse event: fall (mechanical)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 43 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea nausea/vomiting distention constipation ileus diarrhea other gastrointestinal pain abdominal pain
Frequency: 15 affected / 43 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: leg pain gout back pain knee pain hip pain hand pain neck pain arthritis foot pain fracture carpal tunnel shoulder pain low back pain
Frequency: 12 affected / 43 at risk

Adverse event: neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Radiculopathy Sensory deficit motor deficit/weakness cervical radiculopathy spasm mental status change Radiculopathy cervical Sensory deficit
Frequency: 18 affected / 43 at risk

Adverse event: operative
Serious: no
Organ System: Surgical and medical procedures
Notes: Dural Tear Monitoring anomaly (SSEP) Monitoring Anomaly vascular injury
Frequency: 4 affected / 43 at risk

Adverse event: renal
Serious: no
Organ System: Renal and urinary disorders
Notes: oliguria urinary retention hematuria Electrolyte imbalance Other
Frequency: 13 affected / 43 at risk

Adverse event: vascular
Serious: no
Organ System: Vascular disorders
Notes: edema
Frequency: 3 affected / 43 at risk

Adverse event: Wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: prolonged drainage seroma swelling redness pain
Frequency: 1 affected / 43 at risk

Adverse event: other
Serious: no
Organ System: General disorders
Notes: ABLA, Fever, lightheaded/dizzy, pruritis, headache, adhesive reaction, rash, cancer, trigger finger, sore throat, dermatological, tear in the throat, elevated liver enzymes, sinusitis, transaminitis, rhinitis, hearing, bone quality, hyperglycemia
Frequency: 23 affected / 43 at risk

Adverse event: Cardiopulmonary
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypotension tachycardia hypertension DVT hypoxia palpitations other pulmonary arrhythmia bradycardia pulmonary embolism other cardiopulmonary chest pain cough pleural effusion
Frequency: 1 affected / 41 at risk

Adverse event: Fall (mechanical)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: leg pain gout back pain knee pain hip pain hand pain neck pain arthritis foot pain fracture carpal tunnel shoulder pain low back pain
Frequency: 1 affected / 41 at risk

Adverse event: Neurologic
Serious: yes
Organ System: Nervous system disorders
Notes: Radiculopathy Sensory deficit motor deficit/weakness cervical radiculopathy spasm mental status change Radiculopathy cervical Sensory deficit
Frequency: 10 affected / 41 at risk

Adverse event: Renal
Serious: yes
Organ System: Renal and urinary disorders
Notes: oliguria urinary retention hematuria Electrolyte imbalance
Frequency: 1 affected / 41 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Notes: ABLA, Fever, lightheaded/dizzy, pruritis, headache, adhesive reaction, rash, cancer, trigger finger, sore throat, dermatological, tear in the throat, elevated liver enzymes, sinusitis, transaminitis, rhinitis, hearing, bone quality, hyperglycemia
Frequency: 1 affected / 41 at risk

Adverse event: cardiopulmonary
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypotension tachycardia hypertension DVT hypoxia palpitations other pulmonary arrhythmia bradycardia pulmonary embolism other cardiopulmonary chest pain cough pleural effusion
Frequency: 8 affected / 41 at risk

Adverse event: cardiovascular
Serious: no
Organ System: Endocrine disorders
Notes: acute blood loss anemia
Frequency: 1 affected / 41 at risk

Adverse event: fall (mechanical)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 41 at risk

Adverse event: fall (syncope)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: nausea nausea/vomiting distention constipation ileus diarrhea other gastrointestinal pain abdominal pain
Frequency: 8 affected / 41 at risk

Adverse event: musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: leg pain gout back pain knee pain hip pain hand pain neck pain arthritis foot pain fracture carpal tunnel shoulder pain low back pain
Frequency: 6 affected / 41 at risk

Adverse event: neurologic
Serious: no
Organ System: Nervous system disorders
Notes: Radiculopathy Sensory deficit motor deficit/weakness cervical radiculopathy spasm mental status change Radiculopathy cervical Sensory deficit
Frequency: 32 affected / 41 at risk

Adverse event: radiographic
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: adjacent segment degeneration pseudarthrosis
Frequency: 1 affected / 41 at risk

Adverse event: renal
Serious: no
Organ System: Renal and urinary disorders
Notes: oliguria urinary retention hematuria Electrolyte imbalance Other
Frequency: 8 affected / 41 at risk

Adverse event: vascular
Serious: no
Organ System: Vascular disorders
Notes: edema
Frequency: 4 affected / 41 at risk

Adverse event: Wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: prolonged drainage seroma swelling redness pain
Frequency: 2 affected / 41 at risk

Adverse event: other
Serious: no
Organ System: General disorders
Notes: ABLA, Fever, lightheaded/dizzy, pruritis, headache, adhesive reaction, rash, cancer, trigger finger, sore throat, dermatological, tear in the throat, elevated liver enzymes, sinusitis, transaminitis, rhinitis, hearing, bone quality, hyperglycemia
Frequency: 14 affected / 41 at risk