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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
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
KYPHON, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 7
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 8
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Not Applicable 89
Migration of device or device component 65
Leak 52
No code available 48
Break 38
Device operates differently than expected 35
No Known Device Problem 32
Material rigid or stiff 22
Failure to deploy 5
Burst 4
Fluid leak 4
Other (for use when an appropriate device code cannot be identified) 4
Mechanical jam 4
No flow 4
No Information 3
Difficult to open or close 3
Crack 3
Device, or device fragments remain in patient 3
Sticking 3
Device remains implanted 2
Delivery system failure 2
Fracture 2
Device Difficult to Setup or Prepare 2
Decrease in pressure 2
Device expiration issue 2
Failure to Adhere or Bond 2
Loss of or failure to bond 2
No Pressure 2
Shelf life exceeded 2
Packaging issue 1
Unintended movement 1
Misassembled by Users 1
Material integrity issue 1
Difficult to advance 1
Filling problem 1
Clumping in device or device ingredient 1
Coagulation in device or device ingredient 1
Collapse 1
Detachment of device component 1
Material puncture 1
Therapy delivered to incorrect body area 1
Difficult to insert 1
Loose or intermittent connection 1
Mechanical issue 1
Deployment issue 1
Detachment of device or device component 1
Material rupture 1
Unknown (for use when the device problem is not known) 1
Device Issue 1
Structural problem 1
Failure to align 1
Failure to advance 1
Defective item 1
Difficult to remove 1
Unstable 1
Insufficient flow or underinfusion 1
Fitting problem 1
Total Device Problems 469

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 2 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Spine, Inc. II Sep-03-2013
2 DePuy Spine, Inc. II Mar-18-2013
3 Medtronic Spine LLC, formerly Kyphon Inc II Mar-11-2011
4 Stryker Instruments Div. of Stryker Corporation II Aug-15-2016

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