Suturable DuraGen™ PMCF Study

A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™

The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.

This is a multicenter, non-randomized, non-interventional, retrospective Post-Market Clinical Follow-up (PMCF) study to evaluate the occurrence of post-operative cerebrospinal fluid (CSF) leaks within 30 days (and up to 90 days) after use of Suturable DuraGen™ for a supratentorial, infratentorial, or spinal procedure.

Inclusion Criteria:

1. Subject is between 18 and 80 years of age
2. Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation
3. Availability of post-operative assessment results.

Exclusion Criteria:

1. There are no exclusionary criteria for this study population