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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)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
2 0 7 3 6 0 2 3 2 0

Device Problems
Fluid leak 4
Failure to Adhere or Bond 3
No Known Device Problem 2
No Information 1
Hole in material 1
Leak 1
Product quality issue 1
Inadequate storage 1
Device inoperable 1
Component missing 1
Device operates differently than expected 1
Material deformation 1
Total Device Problems 18

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