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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 intervertebral body
Regulation Description Spinal intervertebral body fixation orthosis.
Product CodeKWQ
Regulation Number 888.3060
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  3
  SUBSTANTIALLY EQUIVALENT 8
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 4
ALTIVA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 13
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
CUSTOM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  3
  SUBSTANTIALLY EQUIVALENT 15
EBI, L.P.
  2
  SUBSTANTIALLY EQUIVALENT 9
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 10
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SPINAL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  1
  SUBSTANTIALLY EQUIVALENT 1
K2M
  SUBSTANTIALLY EQUIVALENT 3
LANX
  SUBSTANTIALLY EQUIVALENT 5
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 6
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 31
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 21
OLSEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 4
PIONEER
  SUBSTANTIALLY EQUIVALENT 8
SCIENT'X
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOFAMOR DANEK
  3
  SUBSTANTIALLY EQUIVALENT 4
SPINAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 5
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 2
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 22
SULZER
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  5
  SUBSTANTIALLY EQUIVALENT 17
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 5
TRANS1
  SUBSTANTIALLY EQUIVALENT 6
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 3
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
VERTEBRON, INC.
  SUBSTANTIALLY EQUIVALENT 5
WRIGHT MEDICAL TECHNOLOGY, INC.
  1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Break 275
No Known Device Problem 202
Migration of device or device component 155
Mechanical issue 53
Dislodged or dislocated 51
Malposition of device 47
Implant breakage or physical damage 47
Implant, repositioning of 33
Failure to Adhere or Bond 32
Device or device component damaged by another device 31
Device remains implanted 30
Implant, removal of 30
Fracture 29
Material separation 28
Slippage of device or device component 26
Failure to align 24
Detachment of device or device component 22
Detachment of device component 21
Disassembly 20
Unintended movement 20
Explanted 19
Material fragmentation 16
Difficult to remove 14
No Information 13
Material deformation 12
Failure to osseointegrate 12
Bent 11
Material integrity issue 11
Mechanical jam 11
No code available 11
Loose or intermittent connection 10
Device operates differently than expected 10
Locking mechanism failure 10
Loss of osseointegration 9
Device, or device fragments remain in patient 9
Malfunction 7
Device Issue 7
Improper or incorrect procedure or method 7
Fitting problem 7
Device inoperable 7
Use of Device Issue 6
Metal shedding debris 6
Internal fixation, revision of 6
Loose 6
Positioning Issue 6
Not Applicable 5
Difficult to insert 5
Corrosion 5
Crack 5
Difficult to deploy 5
Difficult to position 4
Component missing 4
Other (for use when an appropriate device code cannot be identified) 4
Disinfection or Sterilization Issue at User Location 3
Dislodged 3
Device Cleaning Issue 3
Component(s), broken 2
Failure to deploy 2
Material discolored 2
Disconnection 2
Normal 2
Defective item 2
Size incorrect for patient 2
Unstable 2
Sticking 2
Replace 2
Torn material 2
Osseointegration issue 1
Packaging issue 1
Mechanics altered 1
Material Protrusion 1
Shaft break 1
Unknown (for use when the device problem is not known) 1
Seal, defective 1
Device or device fragments location unknown 1
Device, removal of (non-implant) 1
Device disinfection or sterilization issue 1
Extrusion 1
Product quality issue 1
Repair 1
Difficult to interrogate 1
Lockout mechanism failure 1
Material frayed 1
Device abrasion from instrument or another object 1
Dislocated 1
Displacement 1
Material erosion 1
Screw tapper, damaged 1
Component falling 1
Total Device Problems 1509

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 1 2 2 5 1 6 5 2 6 1
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems II Apr-25-2012
2 Alliance Partners LLC II Jul-07-2015
3 Alphatec Spine, Inc. II Apr-29-2015
4 Alphatec Spine, Inc. II Aug-27-2012
5 Alphatec Spine, Inc. II Jun-02-2010
6 Biomet Spine, LLC II Nov-03-2015
7 Biomet Spine, LLC II Sep-09-2015
8 Blackstone Medical, Inc. II May-26-2010
9 Blackstone Medical, Inc. II Jan-26-2008
10 Captiva Spine, Inc II May-23-2012
11 Captiva Spine, Inc II May-14-2012
12 DePuy Spine, Inc. II Dec-21-2015
13 Exactech, Inc. II Jul-14-2015
14 Genesys Orthopedic Systems, LLC II Mar-08-2013
15 Integra LifeSciences Corp. II May-13-2011
16 Medtronic Sofamor Danek USA Inc II Oct-10-2012
17 Medtronic Sofamor Danek USA Inc II Jan-11-2012
18 Medtronic Sofamor Danek USA Inc II Mar-27-2007
19 Orthofix, Inc II Feb-25-2014
20 Spinal Solutions, LLC II May-27-2013
21 SpineFrontier, Inc. II Dec-26-2013
22 Stryker Spine II Apr-12-2010
23 Stryker Spine II Nov-24-2009
24 Stryker Spine II Aug-20-2009
25 Stryker Spine III Nov-20-2008
26 Synthes (USA) Products LLC II Apr-20-2016
27 Synthes USA HQ, Inc. II Feb-04-2013
28 Synthes, Inc. II Sep-22-2014
29 Theken Spine Llc II Oct-19-2010
30 Zimmer Inc. II Dec-10-2010
31 Zimmer Inc. II Sep-01-2008
32 Zimmer, Inc. II Nov-18-2013

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