• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Product CodeNEK
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
5 5 3 4 4 6 6 1 4 1

Device Problems
No Known Device Problem 1621
Not Applicable 69
No Information 36
Migration of device or device component 18
Device operates differently than expected 4
Malposition of device 3
Implant, removal of 3
Patient-device incompatibility 2
No code available 2
Operating system becomes non-functional 1
Dislodged or dislocated 1
Implant, repositioning of 1
Inaccurate delivery 1
Collapse 1
Explanted 1
Device maintenance issue 1
User used incorrect product for intended use 1
Device remains implanted 1
Fitting problem 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Inaudible voice prompts 1
Total Device Problems 1771

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 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Sofamor Danek USA Inc II Jun-25-2013

-
-