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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthosis, spinal pedicle fixation
Regulation Description Pedicle screw spinal system.
Product CodeMNI
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
AESCULAP
  SUBSTANTIALLY EQUIVALENT 4
ALLEZ SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 7
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 10
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 5
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 4
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 6
LANX
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 7
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 6
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 28
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 3
SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 5
SPINAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 5
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 11
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 12
SULZER
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 11
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 2
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 1
VERTEBRON, INC.
  SUBSTANTIALLY EQUIVALENT 2
VERTIFLEX
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 104
No Known Device Problem 40
Fracture 26
Dislodged or dislocated 25
Explanted 16
Migration of device or device component 15
Mechanical issue 14
Material integrity issue 14
Detachment of device or device component 12
Loose or intermittent connection 11
Loose 9
Detachment of device component 8
Not Applicable 7
No Information 7
Disassembly 6
Failure to Adhere or Bond 6
Material separation 6
Device remains implanted 5
Implant, removal of 5
Torn material 5
Device or device component damaged by another device 5
Unintended movement 4
Device Issue 4
Difficult to remove 4
Replace 4
Difficult to position 4
Device, or device fragments remain in patient 3
Slippage of device or device component 3
Defective item 3
Malposition of device 3
No code available 3
Connection issue 2
Device operates differently than expected 2
Material deformation 2
Device damaged prior to use 2
Internal fixation, revision of 2
Failure to align 2
Material fragmentation 2
Component(s), broken 2
Disengaged 2
Displacement 1
Bent 1
Difficult to insert 1
Component missing 1
Implant breakage or physical damage 1
Sticking 1
Unstable 1
Improper or incorrect procedure or method 1
Mechanical jam 1
Naturally worn 1
Packaging issue 1
Total Device Problems 410

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 2 5 3 2 0 3 6 1 1 0 0
Class III 0 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Spine II Sep-01-2008
2 Allez Spine, LLC II Oct-28-2008
3 Allez Spine, LLC II Sep-17-2008
4 Allez Spine, LLC II Sep-02-2008
5 Allez Spine, LLC II Mar-11-2008
6 Blackstone Medical, Inc. II Mar-16-2010
7 Blackstone Medical, Inc. II Jul-06-2009
8 Blackstone Medical, Inc. II Dec-11-2007
9 Captiva Spine, Inc II Nov-21-2012
10 EBI, L.P. III Sep-22-2009
11 Exactech, Inc. II Mar-18-2014
12 Medtronic Sofamor Danek Instrument Manufacturing II Feb-08-2007
13 Orthopedic Alliance LLC II Apr-22-2013
14 Spinal Solutions, LLC II May-27-2013
15 SpineFrontier, Inc. II Dec-20-2013
16 SpineFrontier, Inc. II Dec-19-2013
17 SpineFrontier, Inc. II Jul-16-2013
18 Stryker Spine II Aug-22-2012
19 Stryker Spine II Apr-10-2009
20 Synthes (USA) Products LLC II Oct-17-2015
21 Synthes (USA) Products LLC II Jul-20-2012
22 Synthes USA HQ, Inc. II Aug-09-2013
23 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK II Mar-12-2009
24 Zimmer Inc. II Aug-31-2010

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