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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, dermal, for aesthetic use
Product CodeLMH
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
15 50 37 19 21 44 39 61 60 11

Device Problems
No Known Device Problem 1820
Migration of device or device component 64
Needle, separation 46
Spillage, accidental 40
Improper or incorrect procedure or method 17
No Information 10
Detachment of device or device component 9
Foreign material present in device 5
Not Applicable 4
Patient-device incompatibility 4
Use of Device Issue 3
Biofilm coating in device 2
Break 2
Expulsion 2
No code available 1
Material integrity issue 1
Operating system becomes non-functional 1
Occlusion within device 1
Particulates 1
User used incorrect product for intended use 1
Aspiration issue 1
Device operates differently than expected 1
Dislodged or dislocated 1
Unknown (for use when the device problem is not known) 1
Invalid sensing 1
Malposition of device 1
Total Device Problems 2040

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 0 0 0 0 1 0 0 0 2 0
Class III 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Enhancement Medical, LLC I Aug-08-2014
2 Merz Aesthetics, Inc. II Nov-01-2011
3 Merz Aesthetics, Inc. III May-19-2011
4 Merz North America, Inc. II Dec-03-2015
5 Orthovita, Inc., dBA Stryker Orthobiologics. II Mar-30-2015

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