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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 70
No code available 69
Leak 68
No Known Device Problem 46
Break 40
Device operates differently than expected 37
Material rigid or stiff 22
Failure to deploy 5
Filling problem 5
No flow 5
Mechanical jam 4
Fluid leak 4
Fracture 4
Burst 4
Other (for use when an appropriate device code cannot be identified) 4
Device, or device fragments remain in patient 3
Crack 3
Difficult to open or close 3
Sticking 3
No Information 3
Shelf life exceeded 2
Fitting problem 2
Delivery system failure 2
Material integrity issue 2
No Pressure 2
Device remains implanted 2
Clumping in device or device ingredient 2
Coagulation in device or device ingredient 2
Device expiration issue 2
Failure to Adhere or Bond 2
Loss of or failure to bond 2
Device Difficult to Setup or Prepare 2
Decrease in pressure 2
Material puncture 1
Therapy delivered to incorrect body area 1
Difficult to insert 1
Collapse 1
Detachment of device component 1
Loose or intermittent connection 1
Mechanical issue 1
Difficult to remove 1
Material rupture 1
Unknown (for use when the device problem is not known) 1
Component missing 1
Incomplete or missing packaging 1
Device Issue 1
Structural problem 1
Failure to align 1
Failure to advance 1
Defective item 1
Ambient temperature issue 1
Packaging issue 1
Unintended movement 1
Misassembled by Users 1
Deployment issue 1
Detachment of device or device component 1
Difficult to advance 1
Unstable 1
Insufficient flow or underinfusion 1
Failure to expand 1
Total Device Problems 544

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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