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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 194
Migration of device or device component 141
Device remains implanted 53
No code available 25
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
Mechanical issue 8
Dislodged or dislocated 8
Patient-device incompatibility 7
Design/structure problem 7
Size incorrect for patient 6
Internal fixation, revision of 6
Improper or incorrect procedure or method 5
Explanted 5
Malposition of device 5
Detachment of device or device component 5
Device Issue 4
Fitting problem 3
Difficult to insert 3
Dislocated 3
Collapse 3
Fracture 2
Sticking 2
Device inoperable 2
Use of Device Issue 2
Device stops intermittently 1
Device damaged prior to use 1
Incomplete or missing packaging 1
Implant, repositioning of 1
Failure to separate 1
Loose or intermittent connection 1
Misconnection 1
Difficult to deploy 1
Device alarm system issue 1
Displacement 1
Material disintegration 1
Not Applicable 1
Implant breakage or physical damage 1
Blocked connection 1
Connection issue 1
Electromagnetic compatibility issue 1
Material deformation 1
Mechanical jam 1
Total Device Problems 635

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

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