Study: NCT02408471

Adverse event: Ankylosing spondylitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 97 at risk

Adverse event: Deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Deformity - Boutonniere
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Deformity - Swan Neck
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: DIP Mallet
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: DIP pin removal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 97 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 97 at risk

Adverse event: Emergent Prostate Surgery
Serious: yes
Organ System: Renal and urinary disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Excessive Pain
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Flexion Contracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 97 at risk

Adverse event: Flexion Contracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Flexion Contracture, tendon adhesion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Increased Stiffness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 97 at risk

Adverse event: Increased Stiffness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Increased Stiffness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Loss of Motion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 97 at risk

Adverse event: Numbness/Nerve Symptoms
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: OA Contralateral Hand
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: OA w/ midcarpal instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Osteoarthritis w/ midcarpal instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 97 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Pin Protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Pin Removal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: PIP Deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Recurrent Radial Deviation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 97 at risk

Adverse event: Recurrent Ulnar Deviation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 3 affected / 97 at risk

Adverse event: Recurrent Ulnar Deviation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 97 at risk

Adverse event: Recurrent Ulnar Deviation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 97 at risk

Adverse event: Reduction/Loss of Motion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 97 at risk

Adverse event: Removal of Kirschner wires
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Musculoskeletal stiffness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 3 affected / 97 at risk

Adverse event: Musculoskeletal stiffness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 97 at risk

Adverse event: Musculoskeletal stiffness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 97 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 2 affected / 97 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 97 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Surgery on other hand
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Synovitis/Tenosynovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to device
Frequency: 1 affected / 97 at risk

Adverse event: Tendon Adhesion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 3 affected / 97 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Spinal operation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Blistering at tourniquet site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 97 at risk

Adverse event: Bone Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly device related
Frequency: 1 affected / 97 at risk

Adverse event: Bone Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device Related
Frequency: 1 affected / 97 at risk

Adverse event: Bone Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 97 at risk

Adverse event: Calcification PIP joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 97 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 97 at risk

Adverse event: Clicking, popping, pain in right middle finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly device related
Frequency: 1 affected / 97 at risk

Adverse event: Deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Excessive Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device Related
Frequency: 1 affected / 97 at risk

Adverse event: Excessive Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly device related
Frequency: 1 affected / 97 at risk

Adverse event: Excessive Swelling
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 3 affected / 97 at risk

Adverse event: Excessive Swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly device related
Frequency: 1 affected / 97 at risk

Adverse event: Extension lag
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly device related
Frequency: 1 affected / 97 at risk

Adverse event: Flexion Contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly device related
Frequency: 1 affected / 97 at risk

Adverse event: Gastrointestinal-Hospitalized for GI Bleed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 97 at risk

Adverse event: Increased Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly device related
Frequency: 2 affected / 97 at risk

Adverse event: Increased Stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Infection - superficial
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 2 affected / 97 at risk

Adverse event: Lacerated EPB tendon
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Legionella infection
Serious: no
Organ System: Infections and infestations
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Mild, clicking, popping, left index finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly device related
Frequency: 1 affected / 97 at risk

Adverse event: Numbness/Nerve Symptoms
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Pain Onset
Serious: no
Organ System: General disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Pin Protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Pin removal (L) Hand
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: PIP Revision surgery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Recureent Radial/Ulnar Deviation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Recurrent Ulnar Deviation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly device related
Frequency: 1 affected / 97 at risk

Adverse event: Recurrent Ulnar Deviation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 2 affected / 97 at risk

Adverse event: Recurrent Ulnar Deviation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Reduction/loss of motion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly device related
Frequency: 1 affected / 97 at risk

Adverse event: Revision to another PyroCarbon MCP
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Ring & Small claw deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device Related
Frequency: 1 affected / 97 at risk

Adverse event: Scar Adhesion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: squeaking implant
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Device Related
Frequency: 1 affected / 97 at risk

Adverse event: Stiffness in Left small finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Synovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Tendon rupture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk

Adverse event: Knee arthroplasty
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 97 at risk

Adverse event: Triggerfinger RR
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated to device
Frequency: 1 affected / 97 at risk