Two-level Adverse Events

Commonly Reported Adverse Events

Commonly Reported Categories of AEs Through Month 60 Mobi-C Fusion
Neck pain 38.5% 57.1%
Arm pain 23.1% 29.5%
Back pain 32.5% 29.5%
Neurological - upper extremity sensory 41.0% 52.4%
Shoulder pain 27.4% 41.0%
Other pain 65.0% 73.3%
Rates for dysphagia and dysphonia 16.7% 22.9%
Nonunion rate (fusion only) - 14.3%
Heterotopic ossification rate at index levels (Mobi-C only) 9.4%     - 
Unanticipated adverse device effect 0.4% 2.9%

*Note: Adverse event data includes the Mobi-C non-randomized training cases.

One-level Adverse Events

Commonly Reported Adverse Events

Commonly Reported Categories of AEs Through Month 60 Mobi-C Fusion
Neck pain 52.0% 53.1%
Arm pain 38.0% 30.9%
Headache 31.3% 34.6%
Trauma 33.0% 32.1%
Back pain 31.8% 33.3%
Neurological - Neck 25.7% 28.4%
Neurological - upper extremity sensory 46.9% 48.1%
Shoulder Pain  28.5% 27.2%
Other Pain 69.8%  74.1%
Rates for dysphagia and dysphonia 12.3% 22.2%
Local wound events 15.1% 25.9%
Nonunion rate (Fusion only) - 6.2%
Heterotopic ossification rate at index levels (Mobi-C only) 5.6% -
Unanticipated adverse device effect 0.0% 0.0%