Study: NCT00534235

Adverse event: Component Loosening
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 107 at risk

Adverse event: Component Breakage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Tear > 5mm
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Hematoma Requiring Drainage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pain; new, increased frequency, or worsening
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 107 at risk

Adverse event: Pseudarthrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Wound problems
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 107 at risk

Adverse event: Cancer/Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 107 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 107 at risk

Adverse event: Eye, Ear, Nose and Throat (EENT)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 107 at risk

Adverse event: Endocrine/Metabolic
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 107 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 107 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 107 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 107 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 107 at risk

Adverse event: Psychiatric/Substance Abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 107 at risk

Adverse event: Skin and Subcutaneous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Component Loosening
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Component Migration
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Component Breakage
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Nerve injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pain; new, increased frequency, or worsening
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 107 at risk

Adverse event: Pseudarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Wound problems
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 107 at risk

Adverse event: Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 107 at risk

Adverse event: Cancer/Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 107 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 107 at risk

Adverse event: Eye, Ear, Nose, Throat (EENT)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 107 at risk

Adverse event: Endocrine/Metabolic
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 107 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 107 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 8 affected / 107 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 107 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 65 affected / 107 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 107 at risk

Adverse event: Psychiatric/Substance abuse
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 107 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 107 at risk

Adverse event: Skin and Subcutaneous Tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 107 at risk

Adverse event: Component Loosening
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 215 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 215 at risk

Adverse event: Infection (deep)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 215 at risk

Adverse event: Pain; new, increased frequency, or worsening
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 29 affected / 215 at risk

Adverse event: Wound problems
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 215 at risk

Adverse event: Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 215 at risk

Adverse event: Cancer/Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 215 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 215 at risk

Adverse event: Eye, Ear, Nose and Throat (EENT)
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 215 at risk

Adverse event: Endocrine/Metabolic
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 215 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 215 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 215 at risk

Adverse event: Hematological
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 215 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 215 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 215 at risk

Adverse event: Skin and Subcutaneous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Component Loosening
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Component Migration
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 215 at risk

Adverse event: Component Breakage
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 215 at risk

Adverse event: Incidental Durotomy (<= 5mm)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 215 at risk

Adverse event: Pain; new, increased frequency, or worsening
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 61 affected / 215 at risk

Adverse event: Wound problems
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 215 at risk

Adverse event: Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 46 affected / 215 at risk

Adverse event: Cancer/Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 215 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 215 at risk

Adverse event: Eye, Ear, Nose, Throat (EENT)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 215 at risk

Adverse event: Endocrine/Metabolic
Serious: no
Organ System: Endocrine disorders
Frequency: 10 affected / 215 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 215 at risk

Adverse event: Genitourinary
Serious: no
Organ System: General disorders
Frequency: 11 affected / 215 at risk

Adverse event: Hematological
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 215 at risk

Adverse event: Immune
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 215 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 119 affected / 215 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 215 at risk

Adverse event: Psychiatric/Substance abuse
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 215 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 215 at risk

Adverse event: Skin and Subcutaneous Tissue
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 215 at risk