MaxAn Post Market Surveillance Validation

The purpose of this Post Market Surveillance Validation is to document the performance and
clinical outcomes of the MaxAn® Anterior Cervical Plate System. Dr. Park, et.al conducted a
retrospective review and found a positive association between adjacent-level ossification
following anterior cervical plate procedures and the plate-to-disc distance. 1 They concluded
that when the anterior cervical plates were placed at least 5mm away from the adjacent disc
spaces, there was a decrease in the likelihood of moderate-to-severe adjacent-level
ossification. The design of the MaxAn Anterior Cervical Plate and accompanying technique
allows this type of plate placement; therefore we will be looking at the radiographic
outcomes of these subjects and comparing them to the retrospective chart review conducted by
Dr. Park using the MaxAn Technique allows you to achieve plate placement of 5mm from the
supraadjacent level which will help minimize the risk of adjacent level ossification.

Inclusion Criteria:

- Subject is scheduled to undergo a one to three-level primary spinal fusion surgery
between the levels of C2-T1 (Cervical 2 to Thoracic 1) using the MaxAn® Anterior
Cervical Plate System.

- Subject has agreed to participate in this study, sign the informed consent and have
agreed to return for the 6, 12 and 24 month follow-up visits.

- Subjects or their representative must be willing and able to give informed consent.

Exclusion Criteria:

- Subject has spinal infection or inflammation at any level.

- Subject is morbidly obese, defined as a BMI greater than 40.

- Subject has a mental illness, alcoholism or drug abuse.

- Subject has a metal sensitivity/foreign body sensitivity.

- Subject has inadequate tissue coverage over the operative site.

- Subject has an open wound local to the operative area, or rapid joint disease, bone
absorption, osteopenia and/or osteoporosis.

- Female subjects who are pregnant or plan to become pregnant in the next 24 months or
who are lactating.

- Subject who does not meet the specific indications for use of the MaxAn® Anterior
Cervical Plate System.

- Subjects participating in another clinical research study.

- Any previous cervical spinal surgery.