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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Product CodeNEK
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
5 5 3 4 4 6 3

Device Problems
No Known Device Problem 550
Not Applicable 69
Migration of device or device component 18
No Information 4
Implant, removal of 3
Malposition of device 2
Implant, repositioning of 1
Inaccurate delivery 1
No code available 1
Collapse 1
Explanted 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Device remains implanted 1
Operating system becomes non-functional 1
Device maintenance issue 1
Fitting problem 1
Total Device Problems 657

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