Study: NCT01282294

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Device breakage
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 99 at risk

Adverse event: Musculoskeletal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Extraskeletal ossification
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Fistula
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 99 at risk

Adverse event: Fracture delayed union
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 99 at risk

Adverse event: Fracture malunion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Fracture nonunion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 99 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 99 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 99 at risk

Adverse event: Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Complication associated with device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Fracture nonunion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 99 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Periprosthetic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pseudarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 99 at risk

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Soft tissue necrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 99 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 99 at risk

Adverse event: WOUND HEALING DISTURBANCE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 99 at risk

Adverse event: Pathological fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Bone fragmentation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Chondropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 99 at risk

Adverse event: DEPRESSION WORSENED(
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 99 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 99 at risk

Adverse event: Device placement issue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Duodenitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Fracture delayed union
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 99 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Foot deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Impaired healing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 99 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 99 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 99 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 99 at risk

Adverse event: Fracture nonunion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Periprosthetic fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Polyneuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Post-traumatic stress disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 99 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: SKIN NECROSIS(
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Staphylococcal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Stress fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 99 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 99 at risk

Adverse event: Suture related complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 99 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 99 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 99 at risk

Adverse event: Limb asymmetry
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 99 at risk

Adverse event: Urinary tract disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 99 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: WOUND HEALING DISTURBANCE
Serious: no
Organ System: General disorders
Frequency: 2 affected / 99 at risk