• 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 prosthesis, intervertebral disc
Product CodeMJO
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
4 5 1 6 11 6 12 24 11 7

Device Problems
No Known Device Problem 193
Migration of device or device component 137
Device remains implanted 53
No code available 24
Slippage of device or device component 23
Other (for use when an appropriate device code cannot be identified) 15
Implant, removal of 15
Unintended movement 14
Unknown (for use when the device problem is not known) 12
Break 11
No Information 10
Device operates differently than expected 9
Failure to Adhere or Bond 9
Dislodged or dislocated 8
Mechanical issue 8
Design/structure problem 7
Patient-device incompatibility 7
Size incorrect for patient 6
Internal fixation, revision of 6
Detachment of device or device component 5
Malposition of device 5
Improper or incorrect procedure or method 5
Explanted 5
Device Issue 4
Fitting problem 3
Difficult to insert 3
Collapse 3
Dislocated 3
Fracture 2
Device inoperable 2
Use of Device Issue 2
Sticking 2
Material deformation 1
Incomplete or missing packaging 1
Failure to separate 1
Mechanical jam 1
Blocked connection 1
Loose or intermittent connection 1
Device damaged prior to use 1
Device alarm system issue 1
Displacement 1
Implant, repositioning of 1
Not Applicable 1
Difficult to deploy 1
Connection issue 1
Electromagnetic compatibility issue 1
Misconnection 1
Device stops intermittently 1
Implant breakage or physical damage 1
Material disintegration 1
Total Device Problems 629

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 1 0 0 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 Medtronic Sofamor Danek USA Inc II Dec-19-2007

-
-