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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, spinous process spacer/plate
Definition This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.
Product CodeNQO
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
3 1 4 3 1 2 2 2 5 4

Device Problems
Not Applicable 37
No Known Device Problem 19
No Information 9
No code available 9
Migration of device or device component 5
Improper or incorrect procedure or method 3
Fracture 2
Break 1
Dislodged or dislocated 1
Osseointegration issue 1
Total Device Problems 87

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

Recalls
Manufacturer Recall Class Date Posted
1 Kyphon Inc II Sep-29-2008
2 Theragenics Corporation II Mar-31-2009

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