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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intervertebral fusion device with bone graft, lumbar
Regulation Description Intervertebral body fusion device.
Definition Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Product CodeMAX
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 4
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 4
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS
  SUBSTANTIALLY EQUIVALENT 11
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INNOVATIVE SPINAL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
INTERVENTIONAL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 6
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 5
K2M
  SUBSTANTIALLY EQUIVALENT 1
LANX
  SUBSTANTIALLY EQUIVALENT 4
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 5
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 34
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 5
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 3
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 2
SCIENT'X
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 5
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 10
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 5
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 13
SPINEVISION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 17
SYNTHES
  SUBSTANTIALLY EQUIVALENT 2
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 2
TRANS1
  SUBSTANTIALLY EQUIVALENT 3
VERTIFLEX
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Break 236
Migration of device or device component 100
Fracture 63
No Known Device Problem 55
Mechanical issue 35
Device operates differently than expected 35
Fitting problem 34
Material integrity issue 26
Mechanical jam 21
Dislodged or dislocated 20
Loose or intermittent connection 20
Malposition of device 18
Collapse 15
Crack 13
Implant, repositioning of 12
Detachment of device component 11
Unintended movement 11
Difficult to remove 10
Material fragmentation 9
Leak 8
Failure to Adhere or Bond 8
Material deformation 8
Improper or incorrect procedure or method 7
Detachment of device or device component 7
Sticking 7
Explanted 7
Failure to expand 7
Device remains implanted 6
Bent 6
Implant breakage or physical damage 6
Connection issue 6
Implant, removal of 5
Difficult to insert 5
Not Applicable 5
No Information 5
No code available 4
Device, or device fragments remain in patient 4
Disconnection 4
Use of Device Issue 4
Size incorrect for patient 4
Slippage of device or device component 4
Failure to separate 4
User used incorrect product for intended use 3
Difficult to position 2
Material rupture 2
Device expiration issue 2
Failure to deploy 2
Disassembly 2
Device markings issue 2
Material Protrusion 2
Dull 2
No Pressure 2
Packaging issue 2
Positioning Issue 2
Pressure issue 2
Material twisted 2
Device Difficult to maintain 1
Optical issue 1
Patient Data Issue 1
Device handling issue 1
Loss of osseointegration 1
Malfunction 1
Dissatisfaction 1
Cut in material 1
Failure to align 1
Split 1
Patient-device incompatibility 1
Disinfection or Sterilization Issue at User Location 1
Device Issue 1
Internal fixation, revision of 1
Material torqued 1
Naturally worn 1
Expulsion 1
Device sensing issue 1
Defective item 1
Locking mechanism failure 1
Deployment issue 1
Difficult to deploy 1
Accessory incompatible 1
Material disintegration 1
Incorrect display 1
Failure to capture 1
Component falling 1
Intermittent continuity 1
Material separation 1
Failure to power-up 1
Loose 1
Normal 1
Peeled 1
Total Device Problems 937

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

Recalls
Manufacturer Recall Class Date Posted
1 4-Web Inc. II Dec-16-2014
2 Aesculap, Inc. II Jul-25-2013
3 Alphatec Spine, Inc. II May-29-2012
4 Alphatec Spine, Inc. II Nov-12-2009
5 Biomet Spine LLC. II Dec-16-2014
6 Biomet Spine, LLC II Feb-09-2015
7 Captiva Spine, Inc II Jun-07-2012
8 Ebi, Llc II Sep-27-2013
9 Genesys Orthopedic Systems, LLC II Jun-01-2012
10 Medacta Usa II Nov-18-2014
11 Medtronic Sofamor Danek USA Inc II Jul-24-2009
12 Orthofix, Inc. II Feb-15-2012
13 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Jun-26-2015
14 Spinal Elements, Inc II Jan-05-2015
15 Spinal Solutions, LLC II May-27-2013
16 Spinal Solutions, LLC II Apr-22-2013
17 Spine Smith Holdings, LLC II Sep-19-2013
18 Spine Smith Partners LP II Mar-10-2013
19 Spine Wave, Inc. II Sep-11-2013
20 SpineFrontier, Inc. II May-07-2014
21 SpineFrontier, Inc. II Nov-21-2012
22 Stryker Spine II Feb-23-2016
23 Stryker Spine II Oct-20-2008
24 Synthes (USA) Products LLC II Apr-14-2016
25 Synthes Spine II Jan-30-2009
26 Synthes USA (HQ), Inc. II Nov-04-2011
27 Zimmer, Inc. II Jan-09-2013
28 Zimmer, Inc. I Dec-22-2012

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