Two-level Adverse Events Determined to be Major Complications

Success Criteria

The Clinical Events Committee (CEC) independently determined if an adverse event (AE) was a major complication. If so, the study subject was considered a failure.

Results

Two-level AEs Deemed to be a Major Complication
 

Mobi-C
Fusion
 
Major Complications Determined Via CEC Review of Adverse Events (Two-level)
Treatment Group Adverse Event by Subject
Fusion
(n=105)		 Pseudoarthrosis
Worsening arm pain
Worsening neck pain
Vocal cord paralysis
Dysphagia
Degenerative disc disease
Mobi-C
(n=234)		 Recurrent arm pain
Adjacent disc herniation
Recurrent neck pain
Poor function of device and poor attachment to the bone
Dislodged device at C5-C6 (migration of >3 mm)
Impaired light touch
Dysphagia
Headache
Shoulder pain

One-level Adverse Events Determined to be Major Complications

Success Criteria

The Clinical Events Committee (CEC) independently determined if an adverse event (AE) was a major complication. If so, the subject was considered a failure.

Results

One-level AEs Deemed to be a Major Complication

Mobi-C
Fusion
 
Major Complications Determined Via CEC Review of Adverse Events (One-level)
Treatment Group Adverse Event by Subject
Fusion
(n=81)		 Pseudoarthrosis
Worsening arm pain
Worsening neck pain
Misplaced screw
Adjacent disc herniation
Hematoma
Dysphagia
Degenerative disc disease
Mobi-C
(n=179)		 Recurrent arm pain
Adjacent disc herniation
Recurrent neck pain
Malpositioned implant
Subsidence of superior endplate
Anterior ossification
Post-laminectomy syndrome
Upper extremity weakness

 

Mobi-C 7-Year and 10-Year Clinical Results