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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 Thoracolumbosacral pedicle screw 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
INNOVASIS, INC.
  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 87
Mechanical issue 67
No Known Device Problem 50
Fracture 45
Migration of device or device component 43
Material integrity issue 34
Dislodged or dislocated 31
Material deformation 28
Explanted 19
Detachment of device or device component 16
Device operates differently than expected 13
Loose 12
Not Applicable 10
Device remains implanted 9
Loose or intermittent connection 8
No Information 8
Mechanical jam 7
Implant, removal of 7
Detachment of device component 7
Bent 6
Unintended movement 6
Use of Device Issue 5
Disengaged 5
Disassembly 4
Difficult to insert 4
Slippage of device or device component 4
Device inoperable 4
Internal fixation, revision of 3
Shaft break 3
Metal shedding debris 3
Improper or incorrect procedure or method 2
Fitting problem 2
Misassembled 2
Crack 2
Failure to align 2
Implant, repositioning of 2
Device or device component damaged by another device 2
Device-device incompatibility 2
Malposition of device 2
Biocompatibility issue 2
Positioning Issue 2
Material Protrusion 1
No code available 1
Device handling issue 1
Connection issue 1
Human-Device Interface Issue 1
Device Issue 1
Screw head(s), incorrect 1
Device, removal of (non-implant) 1
Dull 1
Malfunction 1
Screw tapper, damaged 1
Difficult to deploy 1
Component falling 1
Failure to Adhere or Bond 1
Compatibility 1
Material fragmentation 1
Nonstandard device or device component 1
Difficult to position 1
Reaction 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Material separation 1
Device damaged prior to use 1
Incomplete or missing packaging 1
Size incorrect for patient 1
Sticking 1
Tip breakage 1
Total Device Problems 597

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

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Oct-29-2012
2 Amendia, Inc II Dec-22-2016
3 EBI, L.P. III Sep-22-2009
4 Exactech, Inc. II Jul-10-2015
5 Stryker Spine II Sep-16-2009
6 Stryker Spine II Jul-07-2009
7 Synthes USA HQ, Inc. II Mar-11-2013
8 X Spine Systems Inc II Jun-22-2015
9 X Spine Systems Inc II Apr-22-2015
10 X Spine Systems Inc II Aug-19-2009
11 XTANT MEDICAL INC II Apr-27-2017

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