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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 3
ALLEZ SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 4
ALTIVA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  2
  SUBSTANTIALLY EQUIVALENT 17
EBI, L.P.
  1
  SUBSTANTIALLY EQUIVALENT 6
ENCORE MEDICAL CORPORATION
  1
  SUBSTANTIALLY EQUIVALENT 2
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 1
LANX
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  1
  SUBSTANTIALLY EQUIVALENT 20
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 4
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
OSTEOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
SCIENT'X
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  1
  SUBSTANTIALLY EQUIVALENT 1
SOFAMOR DANEK
  5
  SUBSTANTIALLY EQUIVALENT 5
SPINAL CONCEPTS
  1
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEVISION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 13
SULZER
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  4
  SUBSTANTIALLY EQUIVALENT 4
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 3
UNITED STATES SURGICAL
  1
  SUBSTANTIALLY EQUIVALENT 3
VERTEBRON, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
  2
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 62
No Known Device Problem 26
Explanted 20
Migration of device or device component 20
Mechanical issue 15
Fracture 14
Loose 12
Device remains implanted 9
Device operates differently than expected 8
Not Applicable 8
Implant, removal of 7
Bent 6
No Information 6
Dislodged or dislocated 6
Material integrity issue 6
Disengaged 5
Loose or intermittent connection 5
Use of Device Issue 4
Detachment of device or device component 4
Mechanical jam 4
Internal fixation, revision of 3
Metal shedding debris 3
Improper or incorrect procedure or method 3
Shaft break 3
Slippage of device or device component 3
Detachment of device component 3
Difficult to insert 2
Misassembled 2
Fitting problem 2
Implant, repositioning of 2
Failure to align 2
Positioning Issue 2
Device or device component damaged by another device 2
Human-Device Interface Issue 1
Material deformation 1
Unintended movement 1
Material Protrusion 1
Device, removal of (non-implant) 1
Malposition of device 1
Connection issue 1
Malfunction 1
No code available 1
Device Issue 1
Screw head(s), incorrect 1
Device damaged prior to use 1
Sticking 1
Tip breakage 1
Device inoperable 1
Size incorrect for patient 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Nonstandard device or device component 1
Reaction 1
Component falling 1
Crack 1
Screw tapper, damaged 1
Difficult to deploy 1
Disassembly 1
Compatibility 1
Total Device Problems 305

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 0 0 3 0 0 1 1 0 3 0
Class III 0 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Oct-29-2012
2 EBI, L.P. III Sep-22-2009
3 Exactech, Inc. II Jul-10-2015
4 Stryker Spine II Sep-16-2009
5 Stryker Spine II Jul-07-2009
6 Synthes USA HQ, Inc. II Mar-11-2013
7 X Spine Systems Inc II Jun-22-2015
8 X Spine Systems Inc II Apr-22-2015
9 X Spine Systems Inc II Aug-19-2009

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