Adverse Events - Orthofix CervicalStim 5505 Manual Del Usuario

Adverse Events Reported at 6 Months by Treatment Group
Control Group (n=160) CervicalStim Device Group (n=163)

Adverse Events

Increased Neck Pain
Shoulder/Arm Pain
Re-Injury to Cervical Spine
Adjacent level pathology
Surgical Complications
LBP/Lumbar pathology
Trauma/Injury(not cervical)
Numbness/Tingling
Headache/Migraine
Nonspecific/Unrelated Pain
Nausea
Dizziness/Vertigo
Rash/Discoloration
Rapid/Irregular Heartbeat
Shortness of Breath
Ringing in Ears
Neurologic Symptom/Stroke
Lump in Throat
Diagnosis of Diabetes
Diagnosis of Breast Cancer
Seizure
Death, Unrelated
Tenderness
Screw Broken
Graft Collapse
Carpal Tunnel Syndrome
Choking Sensation
Cardiac Symptoms
Nephrotic Syndrome
Suicide Attempt
TOTAL
% expressed as number of patients experiencing the event / total number of patients in the group
1
Some patients experienced multiple adverse events
2
* There were several adverse events that were more frequently observed in the CervicalStim device group than in
the control group. Given the types of events, it is unlikely that these adverse events are related to the treatment.
Control Group (n=160)
# (%) of # (%)
Patients
Events
Experiencing
the Event
10 (14.9) 9(5.6)
10(14.9) 9(5.6)
10(14.9) 8(5,0)
3(1.9)
3(4.5)
2(3.0) 2(1.3)
8(11.9) 8(5.0)
2(3.0) 2(1.3)
6(8.9) 6(3.8)
2(3.0) 2(1.3)
2(3.0) 2(1.3)
0
2(3.0) 2(1.3)
0
0
0
0
1(1.5) 1(0.6)
0
0
0
0
0
1(1.5) 1(0.6)
1(1.5) 1(0.6)
1(0.6)
1(1.5)
2(3.0) 2(1.3)
1(0.6)
1(1.5)
1(1.5) 1(0.6)
1(1.5) 1(0.6)
1(1.5) 1(0.6)
67
12
CervicalStim Device Group
of #
1
16(17.8)
16(17.8)
0
0
0
0
0
0
0
0
0
0
47
2
(n=163)
* (%) of # (%)
Events Patients
Experiencing
the Event
15(9.2)
16(9.8)
9(10.0) 9(5.5)
8(8.8) 8(4.9)
7(7.7) 5(3.1)
5(5.5) 5(3.1)
5(5.5) 4(2.5)
4(4.4) 4(2.5)
4(4.4) 4(2.5)
3(3.3) 3(1.8)
2(2.2) 2(1.2)
1(1.1) 1(0.6)
1(1.1) 1(0.6)
1(1.1) 1(0.6)
1(1.1) 1(0.6)
1(1.1) 1(0.6)
1(1.1) 1(0.6)
1(1.1) 1(0.6)
1(1.1) 1(0.6)
1(1.1) 1(0.6)
1(1.1) 1(0.6)
1(1.1) 1(0.6)
0 0
0 0
0 0
0 0
0 0
0 0
0 0
0 0
90 58
of
1
2