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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device thoracolumbosacral pedicle screw system
Regulation Description Pedicle screw spinal system.
Definition Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Product CodeNKB
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 3
AESCULAP
  SUBSTANTIALLY EQUIVALENT 9
ALLEZ SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 5
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 7
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 27
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 11
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 7
GLOBUS
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 16
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INNOVATIVE SPINAL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
LANX
  SUBSTANTIALLY EQUIVALENT 9
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC, INC.
  SE - WITH LIMITATIONS 17
  SUBSTANTIALLY EQUIVALENT 66
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 9
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 7
PIONEER
  SUBSTANTIALLY EQUIVALENT 11
SPINAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 2
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 6
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 5
SPINEVISION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 27
SYNTHES
  SUBSTANTIALLY EQUIVALENT 13
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 4
VERTEBRON, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERTIFLEX
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 11

Device Problems
Break 627
No Known Device Problem 489
Fracture 248
Migration of device or device component 182
Loose or intermittent connection 176
Torn material 139
Material deformation 86
Dislodged or dislocated 83
Mechanical issue 75
Failure to align 69
Detachment of device component 61
Slippage of device or device component 60
Detachment of device or device component 57
Unintended movement 54
No code available 45
Fitting problem 43
No Information 39
Metal shedding debris 38
Explanted 37
Disassembly 35
Difficult to remove 31
Failure to Adhere or Bond 30
Material fragmentation 26
Malposition of device 25
Material separation 24
Device operates differently than expected 23
Device or device component damaged by another device 22
Device inoperable 22
Bent 18
Loose 16
Material integrity issue 16
Difficult to insert 12
Device Issue 12
Use of Device Issue 10
Not Applicable 10
Implant, repositioning of 10
Mechanical jam 9
Implant, removal of 9
Device remains implanted 9
Positioning Issue 7
Device, or device fragments remain in patient 5
Disengaged 5
Device markings issue 5
Implant breakage or physical damage 5
Failure to osseointegrate 4
Improper or incorrect procedure or method 4
Material twisted 4
Noise, Audible 3
Sticking 3
Dull 3
Device or device fragments location unknown 3
Disconnection 3
Crack 3
Component falling 2
Misassembled 2
Failure to disconnect 2
Naturally worn 2
Packaging issue 1
Moisture or humidity problem 1
Extrusion 1
Material Distortion 1
No pacing 1
Failure to separate 1
Defective item 1
Device displays error message 1
Device, removal of (non-implant) 1
Implant Mobility NOS (Not otherwise specified) 1
Patient-device incompatibility 1
Delivery system failure 1
Device-device incompatibility 1
Difficult to advance 1
Malfunction 1
Failure to calibrate 1
Internal fixation, revision of 1
Unknown (for use when the device problem is not known) 1
Component missing 1
Shaft break 1
Unstable 1
Misconnection 1
Unintended system motion 1
Output above specifications 1
Peeled 1
Difficult to position 1
User used incorrect product for intended use 1
Device abrasion from instrument or another object 1
Optical decentration 1
Markings unclear 1
Corrosion 1
Difficult to deploy 1
Failure to deploy 1
Device Cleaning Issue 1
Component(s), broken 1
Entrapment of device or device component 1
High impedance 1
Flaked 1
Failure to flush 1
Total Device Problems 3081

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 0
Class II 2 4 2 3 5 7 5 8 7 4 0
Class III 0 0 0 0 0 0 1 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Spine II Sep-05-2008
2 Abbott Spine II Jul-23-2008
3 Abbott Spine II Oct-02-2007
4 Aesculap Implant Systems LLC II Sep-07-2012
5 Allez Spine, LLC II Oct-28-2008
6 Allez Spine, LLC II Sep-02-2008
7 Alphatec Spine, Inc. II Nov-16-2016
8 Alphatec Spine, Inc. II Jul-22-2014
9 Alphatec Spine, Inc. II Aug-27-2013
10 Alphatec Spine, Inc. II May-28-2013
11 Atlas Spine, Inc. II Aug-27-2012
12 Biomet Spine, LLC II Jul-20-2015
13 Biomet Spine, LLC II Feb-24-2015
14 Biomet Spine, LLC II Feb-11-2015
15 Custom Spine, Inc. II Jul-29-2013
16 DePuy Spine, Inc. II May-26-2015
17 DePuy Spine, Inc. II Jan-24-2013
18 Ebi, Llc II Jan-05-2015
19 Ebi, Llc II Oct-22-2010
20 Genesys Orthopedics Systems, LLC II Sep-22-2014
21 Innovasis, Inc II Jan-19-2016
22 Innovasis, Inc II Jul-16-2014
23 Integra LifeSciences Corp. II Aug-11-2014
24 Integra LifeSciences Corp. II Jul-01-2014
25 Integra LifeSciences Corp. II Feb-07-2014
26 Medtronic Sofamor Danek USA Inc II Jul-25-2011
27 NuVasive Inc II Nov-19-2012
28 OrthoPediatrics Corp II Jan-08-2016
29 Orthofix Inc II Mar-16-2011
30 Orthofix Inc II Mar-08-2011
31 Orthofix, Inc II Jun-10-2015
32 Orthofix, Inc. II Sep-07-2011
33 PIONEER SURGICAL TECHNOLOGY, INC. II Sep-09-2014
34 SeaSpine Inc II Jun-20-2014
35 Spinal Elements, Inc III May-11-2015
36 Spinal Elements, Inc III May-07-2013
37 Stryker Spine II Nov-12-2015
38 Stryker Spine II Jun-05-2012
39 Stryker Spine II Feb-24-2010
40 Stryker Spine II Jun-26-2009
41 Stryker Spine II Sep-21-2007
42 Synthes (USA) Products LLC I Nov-26-2014
43 Synthes USA (HQ), Inc. II Sep-15-2011
44 Synthes USA HQ, Inc. II Nov-26-2013
45 Synthes USA HQ, Inc. II Oct-01-2012
46 Zimmer Inc. II Oct-18-2010
47 Zimmer Inc. II Dec-22-2009
48 Zimmer Spine, Inc. II Mar-18-2016
49 Zimmer, Inc. II Jul-10-2012
50 Zimmer, Inc. II Jul-03-2012

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