Study: NCT03906656

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 102 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 102 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Nasal septum deviation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Systemic scleroderma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Limb operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 102 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Increased fall frequency
Serious: no
Organ System: General disorders
Notes: A significant increase in falls when comparing one home use period to another
Frequency: 6 affected / 102 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 102 at risk

Adverse event: Immunodeficiency syndromes
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Multiple sclerosis
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 102 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 102 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 102 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 102 at risk

Adverse event: Injurious Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: A complete fall, all the way to the ground, that resulted in an injury
Frequency: 21 affected / 102 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 102 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Juvenile idiopathic arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 102 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 102 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 102 at risk

Adverse event: Patella fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Post polio syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Neoplasm progression
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 102 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Battery holder defect
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2 at risk

Adverse event: Beeping
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 2 at risk

Adverse event: Broken Spring
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 102 at risk

Adverse event: Broken Strap
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 102 at risk

Adverse event: Broken foot stirrup
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 102 at risk

Adverse event: Foot plate fracture
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 102 at risk

Adverse event: Joint Malfunction
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 102 at risk

Adverse event: Loose Screw
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 102 at risk

Adverse event: Modified foot plate
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 102 at risk

Adverse event: Poor Fit
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 102 at risk

Adverse event: Unexpected mode switch
Serious: no
Organ System: Product Issues
Notes: Either switching to a freeze/safety mode, or free swing unexpectedly
Frequency: 1 affected / 7 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 45 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 102 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: Intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 46 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Increased fall frequency
Serious: no
Organ System: General disorders
Notes: A significant increase in falls when comparing one home use period to another
Frequency: 1 affected / 88 at risk

Adverse event: Multiple sclerosis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 88 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 88 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Klebsiella infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Injurious Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: A complete fall, all the way to the ground, that resulted in an injury
Frequency: 10 affected / 88 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 88 at risk

Adverse event: Tendon injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 88 at risk

Adverse event: Fibula fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 88 at risk

Adverse event: Juvenile idiopathic arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 88 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 88 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 88 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 88 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Lumbar spinal stenosis
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Additional strap necessary
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 88 at risk

Adverse event: Alignment Issue
Serious: no
Organ System: Product Issues
Notes: A mismatch between the alignment of the orthosis and the subject's physiologic limb
Frequency: 2 affected / 88 at risk

Adverse event: Beeping
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 88 at risk

Adverse event: Bluetooth Malfunction
Serious: no
Organ System: Product Issues
Notes: Connectivity issues to the orthosis via the phone app
Frequency: 3 affected / 88 at risk

Adverse event: Broken Strap
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 88 at risk

Adverse event: Charging Malfunction
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 88 at risk

Adverse event: Clicking/cracking noises
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 88 at risk

Adverse event: Delamination
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 88 at risk

Adverse event: Foot plate fracture
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 88 at risk

Adverse event: Insufficient Padding
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 88 at risk

Adverse event: Joint Malfunction
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 88 at risk

Adverse event: Loose Screw
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 88 at risk

Adverse event: Loss of oil
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 88 at risk

Adverse event: Service Light
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 88 at risk

Adverse event: Unexpected mode switch
Serious: no
Organ System: Product Issues
Notes: Either switching to a freeze/safety mode, or free swing unexpectedly
Frequency: 4 affected / 88 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 88 at risk

Adverse event: Nail bed inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 88 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk