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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 98
No Known Device Problem 37
Fracture 20
Dislodged or dislocated 19
Explanted 16
Migration of device or device component 15
Material integrity issue 11
Loose 9
Mechanical issue 8
Detachment of device component 8
Not Applicable 7
No Information 6
Disassembly 6
Material separation 6
Loose or intermittent connection 6
Detachment of device or device component 6
Implant, removal of 5
Device remains implanted 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
Defective item 3
Malposition of device 3
Slippage of device or device component 3
Device, or device fragments remain in patient 3
Material fragmentation 2
Disengaged 2
Failure to Adhere or Bond 2
Component(s), broken 2
Internal fixation, revision of 2
Failure to align 2
Connection issue 2
No code available 2
Material deformation 2
Mechanical jam 1
Naturally worn 1
Device operates differently than expected 1
Implant breakage or physical damage 1
Sticking 1
Unstable 1
Improper or incorrect procedure or method 1
Component missing 1
Displacement 1
Difficult to insert 1
Difficult to position 1
Total Device Problems 355

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