DuraSeal Exact Spine Sealant System Post-Approval Study (DuraSeal PAS)

• Post-operative surgical site infections [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]
  Deep surgical site infections as defined by the Center for Disease Control criteria.
• Post-operative neurological serious adverse events [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]

This is a non-randomized, post-approval study to further evaluate the rate of post-operative CSF leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.

Prospective Treatment group will be patients that undergo a spinal procedure where a dural opening occurrs and is treated with DuraSeal Exact Spine Sealant System. Retrospective Control group will be patients that have previously undergone a spinal procedure where a dural opening occurred and was treated with anything other than DuraSeal Sealant (Spine or Dural)

• Device: DuraSeal Exact Spine Sealant System
  DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
• Other: Control
  Devices or drugs used to seal the dura

• Treatment
  DuraSeal Exact Spinal Sealant System
  Intervention: Device: DuraSeal Exact Spine Sealant System
• Retrospective Control Arm
  Medical records will be retrospectively reviewed to identify cases where subjects who have undergone a previous spinal procedure where Standard of Care is administered for the treatment of either an intentional or incidental opening of the dura
  Intervention: Other: Control

Inclusion Criteria (Prospective Treatment Arm):

• Subject is 18 years of age or older
• 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.
• Subjects that have a dural opening/tear will be treated with DuraSeal. However, in some instances, there may be an occasion where the investigator chooses not to use DuraSeal due to a specific surgical reason.

Exclusion Criteria (Prospective Treatment Arm):

• The investigator determines that the subject will not be able to comply with the required follow-up visits
• Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site's standard of care is required)

Inclusion Criteria (Retrospective Control Arm):

• Subject is 18 years of age or older
• Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred
• Informed consent has been provided by the subject (if required by the appropriate Institutional Review Board (IRB) of the respective clinical site

Exclusion Criteria (Retrospective Control Arm):

• Subject has received DuraSeal Sealant (either cranial or spinal) during the target procedure
• Pregnant or breastfeeding females (as documented in the medical records)