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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 2017
4 5 1 6 11 6 12 24 11 13 0

Device Problems
No Known Device Problem 237
Migration of device or device component 167
Device remains implanted 54
No code available 31
Slippage of device or device component 23
Unintended movement 17
Implant, removal of 16
Other (for use when an appropriate device code cannot be identified) 15
Break 15
Patient-device incompatibility 13
Dislodged or dislocated 12
Unknown (for use when the device problem is not known) 12
Mechanical issue 10
Malposition of device 10
No Information 10
Device operates differently than expected 9
Failure to Adhere or Bond 9
Use of Device Issue 8
Design/structure problem 7
Difficult to insert 6
Fitting problem 6
Size incorrect for patient 6
Internal fixation, revision of 6
Improper or incorrect procedure or method 5
Explanted 5
Detachment of device or device component 5
Device Issue 4
Expulsion 3
Loose or intermittent connection 3
Material separation 3
Disassembly 3
Dislocated 3
Collapse 3
Fracture 2
Device inoperable 2
Sticking 2
Device stops intermittently 1
Failure to separate 1
Failure to cut 1
Implant, repositioning of 1
Device damaged prior to use 1
Incomplete or missing packaging 1
Misconnection 1
Difficult to deploy 1
Device alarm system issue 1
Displacement 1
Device expiration issue 1
Material disintegration 1
Material deformation 1
Mechanical jam 1
Torn material 1
Not Applicable 1
Electromagnetic compatibility issue 1
Implant breakage or physical damage 1
Blocked connection 1
Connection issue 1
Total Device Problems 762

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