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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device appliance, fixation, spinal interlaminal
Regulation Description Spinal interlaminal fixation orthosis.
Product CodeKWP
Regulation Number 888.3050
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC
  1
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 5
AMERICAN MEDICAL
  1
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  3
  SUBSTANTIALLY EQUIVALENT 24
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 4
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 7
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 7
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
K2M
  SUBSTANTIALLY EQUIVALENT 1
LANX
  SUBSTANTIALLY EQUIVALENT 7
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  9
  SUBSTANTIALLY EQUIVALENT 67
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
Ohio Medical Corporation
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OSTEOTECH, INC.
  2
  SUBSTANTIALLY EQUIVALENT 3
PIONEER
  SUBSTANTIALLY EQUIVALENT 4
SOFAMOR DANEK
  6
  SUBSTANTIALLY EQUIVALENT 7
SPINAL CONCEPTS
  1
  SUBSTANTIALLY EQUIVALENT 4
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 17
SULZER
  SUBSTANTIALLY EQUIVALENT 3
SURGICRAFT CO.
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES
  2
  SUBSTANTIALLY EQUIVALENT 18
T. KOROS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 3
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 4
VERTEBRON, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERTIFLEX
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Break 691
Implant breakage or physical damage 248
No Known Device Problem 247
Failure to align 247
Migration of device or device component 246
Slippage of device or device component 181
Implant, repositioning of 124
Explanted 85
Loose or intermittent connection 79
Implant, removal of 74
Malposition of device 65
Fracture 55
Dislodged or dislocated 49
No code available 46
Device operates differently than expected 44
Difficult to insert 35
Mechanical issue 35
Device remains implanted 35
Disassembly 35
Difficult to remove 34
Unintended movement 33
Metal shedding debris 31
Malfunction 29
Material integrity issue 26
Loose 25
Material deformation 24
Detachment of device or device component 23
Corrosion 23
Disengaged 22
Bent 22
Device or device component damaged by another device 22
Device inoperable 20
Device, or device fragments remain in patient 17
No Information 16
Detachment of device component 15
Replace 15
Torn material 14
Use of Device Issue 13
Failure to Adhere or Bond 10
Implant Mobility NOS (Not otherwise specified) 10
Mechanical jam 9
Peeled 9
Disconnection 8
Internal fixation, revision of 8
Not Applicable 8
Failure to osseointegrate 7
Fitting problem 7
Improper or incorrect procedure or method 6
Device, removal of (non-implant) 6
Naturally worn 6
Osseointegration issue 6
Failure to advance 5
Failure to separate 5
Crack 5
Material fragmentation 5
Material frayed 5
Dislodged 4
Size incorrect for patient 4
Unstable 4
Connection issue 4
Device markings issue 3
Other (for use when an appropriate device code cannot be identified) 3
Unknown (for use when the device problem is not known) 3
Device damaged prior to use 3
Device Issue 3
Failure to disconnect 3
Difficult to position 3
Normal 3
User used incorrect product for intended use 2
Device or device fragments location unknown 2
Locking mechanism failure 2
Loss of osseointegration 2
Defective component 2
Positioning Issue 2
Packaging issue 1
Mechanics altered 1
Material Distortion 1
Material torqued 1
Component missing 1
Implant extrusion 1
Inaccurate synchronization 1
Material rigid or stiff 1
Material separation 1
Shelf life exceeded 1
Dissatisfaction 1
Defective item 1
Misconnection 1
Misplacement 1
Excess flow or overinfusion 1
Device expiration issue 1
Dislocated 1
Degraded 1
Battery charger, defective 1
Component incompatible 1
Intermittent continuity 1
Failure to capture 1
Clumping in device or device ingredient 1
Coagulation in device or device ingredient 1
Collapse 1
Total Device Problems 3247

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

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Mar-18-2013
2 Alphatec Spine, Inc. II Nov-08-2012
3 Alphatec Spine, Inc. II Jan-31-2012
4 Alphatec Spine, Inc. II Dec-14-2009
5 Alphatec Spine, Inc. II Dec-07-2009
6 Biomet Spine, LLC II Sep-10-2015
7 Biomet, Inc. II May-26-2016
8 DePuy Spine, Inc. II Aug-14-2009
9 EBI, L.P. III Sep-22-2009
10 Medtronic Sofamor Danek USA Inc II Aug-19-2011
11 Medtronic Sofamor Danek USA Inc II Jul-25-2011
12 Medtronic Sofamor Danek USA Inc II Dec-13-2007
13 Orthofix, Inc II Feb-28-2013
14 Orthofix, Inc. II Jan-28-2014
15 PIONEER SURGICAL TECHNOLOGY, INC. II Sep-03-2014
16 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II May-26-2016
17 SeaSpine, Inc II Sep-03-2009
18 SpineFrontier, Inc. II Nov-21-2012
19 Stryker Spine I Aug-22-2013
20 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK II Feb-07-2008
21 Zimmer Biomet, Inc. II Jan-09-2016
22 Zimmer Inc. II Oct-08-2010
23 Zimmer Inc. III Dec-14-2009
24 Zimmer Spine, Inc. II Feb-26-2016
25 Zimmer, Inc. II Dec-12-2014

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