• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 641
Implant breakage or physical damage 248
Migration of device or device component 220
No Known Device Problem 211
Slippage of device or device component 181
Failure to align 133
Implant, repositioning of 124
Explanted 85
Implant, removal of 74
Malposition of device 63
Loose or intermittent connection 62
Fracture 49
Device operates differently than expected 44
Dislodged or dislocated 42
Disassembly 35
Difficult to insert 35
Device remains implanted 35
Difficult to remove 34
Unintended movement 33
Mechanical issue 32
No code available 32
Malfunction 29
Loose 25
Detachment of device or device component 23
Corrosion 23
Disengaged 22
Material integrity issue 21
Device inoperable 20
Bent 20
Metal shedding debris 20
Device or device component damaged by another device 20
Device, or device fragments remain in patient 17
Material deformation 16
No Information 16
Detachment of device component 15
Replace 15
Torn material 14
Use of Device Issue 13
Implant Mobility NOS (Not otherwise specified) 10
Failure to Adhere or Bond 10
Disconnection 8
Internal fixation, revision of 8
Mechanical jam 8
Fitting problem 7
Failure to osseointegrate 7
Improper or incorrect procedure or method 6
Osseointegration issue 6
Device, removal of (non-implant) 6
Peeled 6
Naturally worn 6
Crack 5
Failure to separate 5
Failure to advance 5
Not Applicable 5
Material frayed 5
Connection issue 4
Material fragmentation 4
Size incorrect for patient 4
Dislodged 4
Normal 3
Device Issue 3
Difficult to position 3
Other (for use when an appropriate device code cannot be identified) 3
Failure to disconnect 3
Device damaged prior to use 3
Unknown (for use when the device problem is not known) 3
Unstable 3
Defective component 2
Locking mechanism failure 2
Positioning Issue 2
Device markings issue 2
Device or device fragments location unknown 2
User used incorrect product for intended use 2
Loss of osseointegration 2
Misplacement 1
Battery charger, defective 1
Material torqued 1
Dissatisfaction 1
Material rigid or stiff 1
Material separation 1
Excess flow or overinfusion 1
Component incompatible 1
Defective item 1
Packaging issue 1
Shelf life exceeded 1
Implant extrusion 1
Device expiration issue 1
Collapse 1
Material Distortion 1
Mechanics altered 1
Coagulation in device or device ingredient 1
Intermittent continuity 1
Component missing 1
Degraded 1
Failure to capture 1
Clumping in device or device ingredient 1
Misconnection 1
Dislocated 1
Inaccurate synchronization 1
Total Device Problems 2934

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 2
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 DePuy Spine, Inc. II Aug-14-2009
8 EBI, L.P. III Sep-22-2009
9 Medtronic Sofamor Danek USA Inc II Aug-19-2011
10 Medtronic Sofamor Danek USA Inc II Jul-25-2011
11 Medtronic Sofamor Danek USA Inc II Dec-13-2007
12 Orthofix, Inc II Feb-28-2013
13 Orthofix, Inc. II Jan-28-2014
14 PIONEER SURGICAL TECHNOLOGY, INC. II Sep-03-2014
15 SeaSpine, Inc II Sep-03-2009
16 SpineFrontier, Inc. II Nov-21-2012
17 Stryker Spine I Aug-22-2013
18 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK II Feb-07-2008
19 Zimmer Biomet, Inc. II Jan-09-2016
20 Zimmer Inc. II Oct-08-2010
21 Zimmer Inc. III Dec-14-2009
22 Zimmer Spine, Inc. II Feb-26-2016
23 Zimmer, Inc. II Dec-12-2014

-
-