DuraSeal Exact Spine Sealant System Post-Approval Study

Inclusion Criteria:

- Subject is 18 years of age or older

- Subject had a spinal procedure where a dural opening (either intentional or
incidental) occurred and was treated with either:

- DuraSeal™ Exact Spine Sealant (DuraSeal™ Sealant group ONLY) OR

- Any other method of sealing the dura with the exception of DuraSeal™ Sealant
-either spinal or cranial. (Control group ONLY)

- Subject, or authorized representative, has been informed of the nature of the study
and has provided written informed consent approved by the appropriate Institutional
Review Board (IRB) of the respective clinical site prior to the collection of study
data.

- Prospective subjects: Consent must be obtained within 24 hours of surgery stop
time.

- Retrospective subjects (Control group specific): IRB approval may be granted to
individual sites to waive requirement for informed consent.

Exclusion Criteria:

- The investigator determines that the subject will not be able to comply with the
required follow-up visits (not required if subject is being enrolled retrospectively-
control group ONLY)

- Pregnant or breastfeeding females (as documented in the medical records; no testing
beyond the site's standard of care is required)