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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cement, bone, vertebroplasty
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Product CodeNDN
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 6
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 4
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 1
KYPHON, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 7
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Not Applicable 88
Break 6
Migration of device or device component 4
No code available 4
Other (for use when an appropriate device code cannot be identified) 4
Device, or device fragments remain in patient 3
Fluid leak 3
Leak 3
Failure to deploy 2
Loss of or failure to bond 2
Device remains implanted 2
Unknown (for use when the device problem is not known) 1
Device Issue 1
Defective item 1
No Information 1
Total Device Problems 125

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

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Spine, Inc. II Mar-18-2013
2 Medtronic Spine LLC, formerly Kyphon Inc II Mar-11-2011

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