Study: NCT00545818

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Osteopaenia, trauma - fractured toes
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Insufficient renal function (30%)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Undefined heart problems
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Failure knee-prosthesis
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 49 at risk

Adverse event: Hip function failure
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gallbladder removed
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Right hip replacement, post-op infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Armpit abscess due to spider bite.
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Bilateral toe infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Study implant failure
Serious: no
Organ System: Product Issues
Notes: Study implant failure (including implant mobility, excessive bone loss around implant and, implant related pain)
Frequency: 5 affected / 49 at risk

Adverse event: Bridge screw loosening
Serious: no
Organ System: Product Issues
Notes: Loosening of the screw attaching the restoration (the bridge) to the implant abutment.
Frequency: 5 affected / 49 at risk

Adverse event: Abutment fracture
Serious: no
Organ System: Product Issues
Notes: Fracture of the abutment connecting the implant with the restoration
Frequency: 1 affected / 49 at risk

Adverse event: Fracture of temporary bridge
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 49 at risk

Adverse event: Liver cancer
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Broken pelvis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pneumonitis - Non Hodgkin disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hip fracture due to car accident
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

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

Adverse event: Eye cancer (basal cell carcinoma)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Squamous cell skin cancer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Study implant failure
Serious: no
Organ System: Product Issues
Notes: Study implant failure (including implant mobility, excessive bone loss around implant and, implant related pain)
Frequency: 1 affected / 46 at risk

Adverse event: Bridge screw loosening
Serious: no
Organ System: Product Issues
Notes: Loosening of the screw attaching the restoration (the bridge) to the implant abutment.
Frequency: 5 affected / 46 at risk

Adverse event: Abutment fracture
Serious: no
Organ System: Product Issues
Notes: Fracture of the abutment connecting the implant with the restoration
Frequency: 3 affected / 46 at risk

Adverse event: Fracture of temporary bridge
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 46 at risk