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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 63
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 440
No Known Device Problem 351
Fracture 163
Loose or intermittent connection 126
Migration of device or device component 113
Torn material 90
Mechanical issue 60
Dislodged or dislocated 58
Detachment of device component 57
Detachment of device or device component 48
Fitting problem 43
Failure to align 41
Material deformation 41
Explanted 38
Slippage of device or device component 38
No Information 36
No code available 28
Failure to Adhere or Bond 26
Unintended movement 25
Difficult to remove 24
Metal shedding debris 24
Malposition of device 20
Material separation 20
Loose 16
Device operates differently than expected 16
Bent 15
Disassembly 14
Material fragmentation 12
Implant, repositioning of 10
Device Issue 10
Implant, removal of 9
Device remains implanted 9
Device inoperable 9
Not Applicable 9
Difficult to insert 8
Material integrity issue 8
Mechanical jam 8
Use of Device Issue 7
Disengaged 5
Implant breakage or physical damage 5
Device, or device fragments remain in patient 5
Failure to osseointegrate 4
Improper or incorrect procedure or method 4
Device or device fragments location unknown 3
Sticking 3
Disconnection 3
Noise, Audible 3
Positioning Issue 2
Component falling 2
Crack 2
Device markings issue 2
Device or device component damaged by another device 2
Naturally worn 2
Packaging issue 1
Moisture or humidity problem 1
Material Distortion 1
Difficult to advance 1
Extrusion 1
Patient-device incompatibility 1
Delivery system failure 1
Device displays error message 1
Device, removal of (non-implant) 1
Implant Mobility NOS (Not otherwise specified) 1
Failure to separate 1
Defective item 1
Unknown (for use when the device problem is not known) 1
Component missing 1
Internal fixation, revision of 1
Dull 1
Malfunction 1
Failure to calibrate 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
Difficult to position 1
User used incorrect product for intended use 1
No pacing 1
Total Device Problems 2153

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

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