Study: NCT04653051

Adverse event: Altered sensation of the median nerve
Serious: yes
Organ System: Nervous system disorders
Notes: Altered sensation of the median nerve
Frequency: 1 affected / 111 at risk

Adverse event: Car accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Fracture of ribs and hip due to a car accident
Frequency: 1 affected / 111 at risk

Adverse event: Reduced mobility
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reduced mobility, as patient unable to use the left thumb which heavily impacts the ability to perform any task with left hand - patient reported this was due to a ruptured tendon as a result of plaster cast
Frequency: 1 affected / 111 at risk

Adverse event: Osteochondrosis
Serious: yes
Organ System: Vascular disorders
Notes: Patient is experiencing ongoing significant pain due to Kienbock's disease
Frequency: 1 affected / 111 at risk

Adverse event: Pain due to altered sensation
Serious: no
Organ System: Nervous system disorders
Notes: Patient experiences shooting pains in hand. Surgery wasn't offered as wasn't thought to improve outcome. Subject is seeing independent specialist and was discharged from clinic.
Frequency: 1 affected / 111 at risk

Adverse event: Plate removal
Serious: no
Organ System: Nervous system disorders
Notes: Patient had wrist plate removed due to "rubbing against nerve-screw was pressing against skin". Patient pointed out a small lump on the radial border of wrist which is quite tender and possibilities this may be a screw.
Frequency: 1 affected / 111 at risk

Adverse event: Shoulder/ arm pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient received epidural injection for trapped nerve/shoulder/arm pain
Frequency: 1 affected / 111 at risk

Adverse event: Pain in wrist
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Ongoing pain in wrist - described as "mild"
2. Regular ongoing pain in wrist since operation when performing tasks with affected wrist
3. Significant pain when using wrist and unable to straighten ring and little finger also weakness in wrist
Frequency: 3 affected / 111 at risk

Adverse event: Loose screw
Serious: no
Organ System: Product Issues
Notes: Patient said a screw was "loose" according to the x-rays during clinic appointment - has not caused any issues
Frequency: 1 affected / 111 at risk

Adverse event: Stiffness and pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Stiffness and pain causing difficulty moving the hand-removal of used K-wires
2. Shoulder pain and stiffness
3. Stiffness in wrist
Frequency: 3 affected / 111 at risk

Adverse event: Shooting spasm pains
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Experiences shooting spasm pains down arm and wrist - especially when using wrist a lot during working. Pain is not bad enough to stop subject from doing anything.

2- Patient experiences very occasional sudden shooting pain - no clear cause
Frequency: 2 affected / 111 at risk

Adverse event: Rotator cuff impingement
Serious: no
Organ System: Nervous system disorders
Notes: Rotator cuff impingement with long head of biceps medialisation. Severe stiffness due to multiple injuries and prolonged reduced mobilization.
Frequency: 1 affected / 111 at risk

Adverse event: Collapsed joint line
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Patient reported there was a gap between the bones in wrist. Pain when using wrist and a 'clunking'
2. Pain is flaring up from time to time. Very active and pain mostly occurs recently during activities like climbing Nothing to note in X-Rays
Frequency: 2 affected / 111 at risk

Adverse event: Mild ache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Patient experiences 'clicking' in wrist when moving with a "mild ache"
2. Patient experiences occasional mild pain when it's cold
Frequency: 2 affected / 111 at risk

Adverse event: Intermittent pain and instability
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient experiences intermittent pain in wrist and mentioned experiencing ongoing instability and it has some deformity -There was pre-existing instability of the DRUJ therefore the complication is unrelated to the device.
Frequency: 1 affected / 111 at risk

Adverse event: Lower Respiratory Tract Infection (LRTI)
Serious: no
Organ System: Infections and infestations
Notes: Patient developed a LRTI post op and was given a course of antibiotics - extended hospital stay
Frequency: 1 affected / 111 at risk

Adverse event: Arthritis
Serious: no
Organ System: Immune system disorders
Notes: 1. Reduced wrist function and occasional pain due to ongoing arthritis
2. Patient developed arthritis in wrist
3. Arthritis in wrist -pain, mostly in cold weather. Post-OP onset
4. Arthritis in fingers- regular ongoing pain in wrist
Frequency: 4 affected / 111 at risk

Adverse event: Low wrist function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient attributed lower rated wrist function due to "stiff fingers"- unable to make a fist with left hand
Frequency: 1 affected / 111 at risk

Adverse event: Additional fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 1. Fall-no fracture but ligaments in arm/shoulder injured- pain affects wrist function
2. Fall, mobilizing with crutches-numbness in thumb and tip of little finger-reduced finger mobility
3. Patient had a subsequent fall, thumb injured- ongoing pain
Frequency: 3 affected / 111 at risk

Adverse event: Discomfort and pain
Serious: no
Organ System: Product Issues
Notes: 1- Patient experienced discomfort and pain following operation. Shooting pain into ring and little finger, reduced grip and trouble rotating wrist
Frequency: 1 affected / 111 at risk

Adverse event: Multiple injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Polytrauma - long hospital stay
Frequency: 6 affected / 111 at risk

Adverse event: Aching and pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject experiences aching and some pain depending on the weather - affects subject intermittently
Frequency: 1 affected / 111 at risk

Adverse event: Plate removal
Serious: no
Organ System: Product Issues
Notes: 1. Ongoing pain and eventually had metalwork removed
2. Pain caused plate removal
3. Ulna plate fixation failed in osteoporotic bone causing need for revision ulna fixation
Frequency: 3 affected / 111 at risk

Adverse event: Long recovery
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Recovery after surgery took longer than the time frame the surgeon gave. Patient struggled to move fingers and wrist significantly post-surgery
Frequency: 1 affected / 111 at risk

Adverse event: Complex regional pain syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient experiences significant pain when lifting any heavy object and has ongoing weakness in affected hand/wrist
Frequency: 1 affected / 111 at risk

Adverse event: Pain in wrist
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Patient's wrist was still quite painful, causing some difficulty sleeping at night and has minimal range of movement - wrist was slightly swollen, slightly hypersensitive thumb with some occasional pins and needles
2. Pain and discomfort in wrist
Frequency: 2 affected / 111 at risk

Adverse event: Reduced ROM
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Slightly reduced ROM-wrist flexion and some resistance when making a tight fist
2. Reduced ROM in wrist
3. Slight reduced range of motion- hand not flat during yoga
4. Stiffness, reduced ROM and some pain
5. Reduced wrist ROM affecting activities
Frequency: 5 affected / 111 at risk

Adverse event: Pain when lifting heavy objects
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient struggles with pain when lifting heavy objects (more than 5kg) and with repeated movements like using a tin opener or using bathroom tissue. Patient avoids these activities.
Frequency: 1 affected / 111 at risk

Adverse event: Occasional pain and slightly reduced ROM
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient since operation gets occasional pain and slight reduced ROM, only at it's worse during cold weather. The pain rarely affects the patient.
Frequency: 1 affected / 111 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Patient experiences numbness in thumb, index \& middle fingers which is related to the nerve dysfunction
Frequency: 1 affected / 111 at risk

Adverse event: Swollen wrist
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Swollen wrist with a globally reduced range of motion which results to the hand movement stiffness
Frequency: 1 affected / 111 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pain post operatively leading to prolonged stay. Background of Polymyalgia which can often predispose to pain control issues. Difficult to say if pain from swelling of original fracture of from procedure.
Frequency: 1 affected / 111 at risk

Adverse event: Shooting nerve pain in wrist
Serious: no
Organ System: Nervous system disorders
Notes: Patient experiences shooting/nerve pain in wrist when completing certain tasks like using a bathroom tissue. Does not occur often but can be really painful
Frequency: 1 affected / 111 at risk

Adverse event: Stitches opened
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Patient's stitches/wound opened up the day after surgery - bleeding inside the cast. Went t back to hospital to have her wound re-dressed and re-cast.
Frequency: 1 affected / 111 at risk

Adverse event: Bones moving forward
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Plate has not stopped the bones from moving forward
Frequency: 1 affected / 111 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1. Patient experiences tingling sensation when touching the skin over the plate
2. Patient experiences regular nerve pain/twinges, and pins \& needles
Frequency: 2 affected / 111 at risk

Adverse event: Clicking and minor weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient experiences clicking in wrist when moving and some minor weakness when lifting heavy objects
Frequency: 1 affected / 111 at risk

Adverse event: Thicker wrist
Serious: no
Organ System: Product Issues
Notes: Patient's operated wrist is thicker than other (non-operated) wrist
Frequency: 1 affected / 111 at risk

Adverse event: Plate pincing nerve
Serious: no
Organ System: Product Issues
Notes: Patient is complaining of the plate pinching a nerve in wrist causing issues with thumb (stiffness and poor flexibility)
Frequency: 1 affected / 111 at risk

Adverse event: Loss of power and grip strenght
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Small amount of loss of power \& grip strength
2. Reduced grip strength-doesn't impact activities
3. Reported lower grip strength in affected hand/wrist
4. Reduced strength and infrequent pain-worse/intense when using wrist for certain activities
Frequency: 4 affected / 111 at risk

Adverse event: Concurring spinal injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Patient had delayed discharge due to concurring spinal injuries
Frequency: 1 affected / 111 at risk

Adverse event: Collapse at fracture site
Serious: no
Organ System: Product Issues
Notes: Collapse at fracture site resulting in metalwork removal (plate and screws)
Frequency: 1 affected / 111 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain/nerve pain in back that sometimes affects both arms
Frequency: 1 affected / 111 at risk

Adverse event: Stiffness and irritation caused by the plate
Serious: no
Organ System: Product Issues
Notes: 1. Patient experienced stiffness of wrist (no pain) and irritation cause by the plate
2. Patient experiences significant stiffness and reduced range of motion resulting in the plate being removed. Stiffness remains after device removal
Frequency: 2 affected / 111 at risk

Adverse event: Dull ache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient experiences dull ache in wrist, this pain can prevents patient from doing push-ups and from writing for extended periods of time
Frequency: 1 affected / 111 at risk

Adverse event: Wrist weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient experiences some wrist weakness
Frequency: 1 affected / 111 at risk

Adverse event: Enlarged scar
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Pins and needles feeling
Serious: no
Organ System: Nervous system disorders
Notes: 1. Patient experiences ongoing pins and needles in affected hand/wrist
2. Patient experiencing pins \& needles in wrist, extending to forearm for the last 1-2 years
Frequency: 2 affected / 111 at risk

Adverse event: Pain combined with stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Patient has ongoing pain/aches in wrist, stiffness and reduced grip strength making majority of activities more difficult
2. Patient gets pain when performing repeated wrist movements, has increased stiffness \& reduced ROM when twisting wrist
Frequency: 2 affected / 111 at risk

Adverse event: Pain when performing repeated wrist movements
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 111 at risk

Adverse event: Reduced strength
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 1. Patient has reduced level of strength in left hand
2. Patient's wrist fatigues quickly and loses strength during use. The patient also experiences regular ongoing pain in wrist
Frequency: 2 affected / 111 at risk

Adverse event: Inpatient fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Inpatient fall sustaining skull fracture with concurrent subdural hematoma - longer admission
Frequency: 1 affected / 111 at risk