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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sealant, dural
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.
Product CodeNQR
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
6 4 15 3 13 3

MDR Year MDR Reports MDR Events
2021 20 20
2022 39 39
2023 19 19
2024 20 20
2025 59 59
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 50 50
Improper Chemical Reaction 31 31
Chemical Problem 15 15
Coagulation in Device or Device Ingredient 10 10
Output Problem 8 8
Fluid/Blood Leak 8 8
Leak/Splash 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Clumping in Device or Device Ingredient 3 3
Patient Device Interaction Problem 3 3
Device Ingredient or Reagent Problem 2 2
Physical Resistance/Sticking 2 2
Material Rupture 2 2
Fumes or Vapors 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Failure to Power Up 1 1
Use of Device Problem 1 1
Obstruction of Flow 1 1
Device Handling Problem 1 1
Unexpected Color 1 1
Product Quality Problem 1 1
Inaccurate Delivery 1 1
Failure to Infuse 1 1
Failure to Advance 1 1
Gel Leak 1 1
Nonstandard Device 1 1
Device Appears to Trigger Rejection 1 1
Failure to Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 86 86
Cerebrospinal Fluid Leakage 23 23
Post Operative Wound Infection 18 18
Unspecified Infection 13 13
No Consequences Or Impact To Patient 5 5
Fistula 4 4
Hematoma 4 4
Bacterial Infection 3 3
Insufficient Information 3 3
Paresthesia 2 2
Headache 2 2
Hypersensitivity/Allergic reaction 2 2
Foreign Body Reaction 1 1
Wound Dehiscence 1 1
Asthma 1 1
Inflammation 1 1
Nausea 1 1
Nerve Damage 1 1
Neuropathy 1 1
Paralysis 1 1
Quadriplegia 1 1
Skin Tears 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Nervous System Injury 1 1
Neuralgia 1 1
Wheezing 1 1
Intervertebral Disc Compression or Protrusion 1 1
Meningitis 1 1
Spinal Cord Injury 1 1

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