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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 15

Device Problems
No Known Device Problem 295
Migration of device or device component 192
Device remains implanted 54
No code available 34
Unintended movement 26
Slippage of device or device component 23
Implant, removal of 16
Malposition of device 15
Other (for use when an appropriate device code cannot be identified) 15
Break 15
Patient-device incompatibility 13
Dislodged or dislocated 13
No Information 12
Unknown (for use when the device problem is not known) 12
Mechanical issue 12
Failure to Adhere or Bond 9
Use of Device Issue 8
Device operates differently than expected 8
Design/structure problem 7
Difficult to insert 6
Size incorrect for patient 6
Internal fixation, revision of 6
Fitting problem 6
Improper or incorrect procedure or method 5
Device Issue 5
Detachment of device or device component 5
Explanted 5
Loose or intermittent connection 4
Disassembly 4
Collapse 3
Fracture 3
Dislocated 3
Material separation 3
Expulsion 3
Sticking 2
Metal shedding debris 2
Device inoperable 2
Unstable 1
Device damaged prior to use 1
Incomplete or missing packaging 1
Device stops intermittently 1
Misconnection 1
Displacement 1
Material erosion 1
Device expiration issue 1
Material fragmentation 1
Crack 1
Difficult to deploy 1
Material disintegration 1
Device alarm system issue 1
Material deformation 1
Mechanical jam 1
Electromagnetic compatibility issue 1
Blocked connection 1
Connection issue 1
Implant, repositioning of 1
Failure to separate 1
Failure to cut 1
Implant breakage or physical damage 1
Not Applicable 1
Torn material 1
Total Device Problems 876

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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