Study: NCT00667849

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Resulted in hospitalization Not related to device
Frequency: 1 affected / 250 at risk

Adverse event: Infection, tissue
Serious: yes
Organ System: Infections and infestations
Notes: Resulted in hospitalization, was a life threatening situation, necessitated medical surgical intervention to preclude primary impairment of body function or permanent damage to a body structure.

Not related to device.
Frequency: 1 affected / 250 at risk

Adverse event: Broken screw
Serious: yes
Organ System: Surgical and medical procedures
Notes: Resulted in hospitalization Not related to device
Frequency: 1 affected / 250 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: tendonitis of hip; resulted in hospitalization
Frequency: 1 affected / 250 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Edema of left lower extremity
Frequency: 18 affected / 250 at risk

Adverse event: Other, not listed on AE form
Serious: no
Organ System: General disorders
Frequency: 7 affected / 250 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 250 at risk

Adverse event: Infection, tissue
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 250 at risk

Adverse event: Wound complication
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 250 at risk

Adverse event: accident/fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 250 at risk

Adverse event: Non-union
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 250 at risk

Adverse event: Other local event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 250 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 48 affected / 250 at risk

Adverse event: Rash/redness at treated area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 250 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: abnormal troponin level and nausea Resulted in hospitalization Not related to device
Frequency: 1 affected / 251 at risk

Adverse event: Renal dysfunction (creatinine 2x BL level
Serious: yes
Organ System: Renal and urinary disorders
Notes: Resulted in hospitalization Not related to device
Frequency: 1 affected / 251 at risk

Adverse event: Broken screw
Serious: yes
Organ System: Surgical and medical procedures
Notes: Resulted in hospitalization Not related to device
Frequency: 1 affected / 251 at risk

Adverse event: sternal wire closure disruption
Serious: yes
Organ System: Cardiac disorders
Notes: resulted in hospitalization
Frequency: 1 affected / 251 at risk

Adverse event: cough, vomiting, leukocytosis, increased troponin
Serious: yes
Organ System: Gastrointestinal disorders
Notes: possible gastroenteritis resulted in hospitalization
Frequency: 1 affected / 251 at risk

Adverse event: infection tissue
Serious: yes
Organ System: Infections and infestations
Notes: cellulitis; resulted in hospitalization
Frequency: 1 affected / 251 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Edema of left lower extremity
Frequency: 15 affected / 251 at risk

Adverse event: Other, not listed on AE form
Serious: no
Organ System: General disorders
Frequency: 21 affected / 251 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 251 at risk

Adverse event: Infection, tissue
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 251 at risk

Adverse event: Wound complication
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 251 at risk

Adverse event: accident/fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 251 at risk

Adverse event: Non-union
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 251 at risk

Adverse event: Other local event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 251 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Frequency: 49 affected / 251 at risk

Adverse event: Rash/redness at treated area
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 251 at risk