Modification to Townley Transfacepedicular Screw Fixation System

The TOWNLEYTMTransfacetpedicular Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods. The first fixation method uses the TOWNLEYTM

Transfacetpedicular Screws as just facet fixation screws, where the screws are inserted bilaterally

through the superior side of the facet, across the facet joint at (usually) a single level, and into the

pedicle.

In the second fixation method, the TOWNLEYTMTransfacetpedicular Screws are inserted bilaterally

through the superior side of the facet, across the facet joint, and into the pedicle at multiple levels at the

same time that a DYNALOKB Plate is attached to the base of the spinous processes at the corresponding

levels with TOWNLEYTMTransfacetpedicular Screws. The second fixation method should be used when

the spine has increased instability or multiple levels need to be 'fused. Bone graft must be used for both

fixation methods.

For both methods, this system is indicated for the posterior surgical treatment of any or all of the

following at the C2 to T3 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or

dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudarthrosis or failed previous fusions which

are symptomatic or which may cause secondary instability or deformity; 5 ) Degenerative diseases which

include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as

confirmed by patient history with degeneration of the disc as confirmed by radiographic studies andor;

(b) degenerative disease of the facets with instability.