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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, invasive bone growth
Product CodeLOE
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
1 3 0 0 1 2 4 2 4 3

Device Problems
Detachment of device component 2
No Information 2
Corrosion 1
Difficult to insert 1
Replace 1
Wire(s), breakage of 1
Device, removal of (non-implant) 1
Device operates differently than expected 1
Total Device Problems 10

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