Definition: Dural Sealants Are Devices Intended To Aid In Preventing Cerebrospinal Fluid Leakage Through Suture-approximated Dural Wound Edges. The Sealant Is Sprayed Or Layered Onto Sutured Dural Wound Edges And Allowed To Polymerize In Place.
| Device Type ID | 3853 |
| Device Name | Sealant, Dural |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NQR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3853 |
| Device | Sealant, Dural |
| Product Code | NQR |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 27 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Fluid Leak | 11 |
Device Operates Differently Than Expected | 9 |
Failure To Adhere Or Bond | 6 |
Leak / Splash | 6 |
Material Integrity Problem | 4 |
Product Quality Problem | 3 |
Device Operational Issue | 3 |
Contamination During Use | 2 |
Chemical Problem | 2 |
Insufficient Information | 2 |
Shelf Life Exceeded | 1 |
Packaging Problem | 1 |
Improper Chemical Reaction | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Sticking | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Deformation | 1 |
Hole In Material | 1 |
Off-Label Use | 1 |
Patient Device Interaction Problem | 1 |
Inadequate Storage | 1 |
Device Displays Incorrect Message | 1 |
Component Missing | 1 |
Device Inoperable | 1 |
| Total Device Problems | 100 |