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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, for degenerative disc disease
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 in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at l5-s1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.
Product CodeNKB
Regulation Number 888.3070
Device Class 3


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 65
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 527
No Known Device Problem 423
Fracture 203
Loose or intermittent connection 150
Migration of device or device component 138
Torn material 115
Dislodged or dislocated 82
Mechanical issue 67
Detachment of device component 58
Slippage of device or device component 53
Detachment of device or device component 52
Material deformation 50
Failure to align 47
Fitting problem 43
Unintended movement 41
No Information 41
Explanted 38
Metal shedding debris 34
No code available 29
Failure to Adhere or Bond 27
Difficult to remove 27
Malposition of device 22
Material separation 21
Device inoperable 21
Material fragmentation 21
Disassembly 17
Bent 17
Device operates differently than expected 17
Loose 16
Device Issue 12
Difficult to insert 11
Implant, repositioning of 10
Material integrity issue 10
Not Applicable 10
Mechanical jam 9
Implant, removal of 9
Use of Device Issue 9
Device remains implanted 9
Device, or device fragments remain in patient 5
Disengaged 5
Device markings issue 5
Implant breakage or physical damage 5
Device or device component damaged by another device 4
Material twisted 4
Failure to osseointegrate 4
Improper or incorrect procedure or method 4
Positioning Issue 4
Noise, Audible 3
Device or device fragments location unknown 3
Sticking 3
Disconnection 3
Crack 3
Component falling 2
Corrosion 2
Naturally worn 2
Moisture or humidity problem 1
Packaging issue 1
No pacing 1
Difficult to deploy 1
Failure to deploy 1
Device Cleaning Issue 1
Component(s), broken 1
Flaked 1
Failure to flush 1
Optical decentration 1
High impedance 1
Unstable 1
Shaft break 1
Markings unclear 1
Device abrasion from instrument or another object 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 displays error message 1
Device, removal of (non-implant) 1
Failure to separate 1
Defective item 1
Internal fixation, revision of 1
Dull 1
Malfunction 1
Failure to calibrate 1
Unknown (for use when the device problem is not known) 1
Component missing 1
Material Distortion 1
Extrusion 1
Device-device incompatibility 1
Difficult to advance 1
Patient-device incompatibility 1
Delivery system failure 1
Implant Mobility NOS (Not otherwise specified) 1
Total Device Problems 2585

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