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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
  SUBSTANTIALLY EQUIVALENT 8
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 3
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.
  SUBSTANTIALLY EQUIVALENT 15
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 3
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 9
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 9
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SPINAL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 3
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
LANX
  SUBSTANTIALLY EQUIVALENT 5
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 6
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 27
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 19
OLSEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 8
SCIENT'X
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 3
SPINAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 5
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 2
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 18
SULZER
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 17
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 5
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 5
TRANS1
  SUBSTANTIALLY EQUIVALENT 6
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
VERTEBRON, INC.
  SUBSTANTIALLY EQUIVALENT 5
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Break 171
Migration of device or device component 111
No Known Device Problem 88
Implant breakage or physical damage 47
Malposition of device 41
Implant, repositioning of 33
Implant, removal of 30
Device remains implanted 30
Device or device component damaged by another device 25
Failure to align 22
Dislodged or dislocated 20
Failure to Adhere or Bond 20
Explanted 19
Disassembly 17
Detachment of device component 15
Slippage of device or device component 11
Detachment of device or device component 11
Locking mechanism failure 10
Device, or device fragments remain in patient 9
Difficult to remove 9
Malfunction 7
Device inoperable 7
Internal fixation, revision of 6
Loose 6
No Information 6
Device Issue 6
Difficult to deploy 5
Use of Device Issue 5
Metal shedding debris 5
Other (for use when an appropriate device code cannot be identified) 4
Mechanical issue 4
Component missing 4
Improper or incorrect procedure or method 4
Difficult to insert 4
Material separation 3
Corrosion 3
Dislodged 3
Normal 2
Size incorrect for patient 2
No code available 2
Difficult to position 2
Not Applicable 2
Component(s), broken 2
Failure to osseointegrate 2
Fracture 2
Failure to deploy 2
Replace 2
Disconnection 2
Displacement 1
Material frayed 1
Mechanics altered 1
Dislocated 1
Bent 1
Screw tapper, damaged 1
Repair 1
Crack 1
Device abrasion from instrument or another object 1
Lockout mechanism failure 1
Unknown (for use when the device problem is not known) 1
Defective item 1
Device or device fragments location unknown 1
Sticking 1
Shaft break 1
Fitting problem 1
Seal, defective 1
Loss of osseointegration 1
Device, removal of (non-implant) 1
Osseointegration issue 1
Total Device Problems 863

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

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems II Apr-25-2012
2 Alphatec Spine, Inc. II Aug-27-2012
3 Alphatec Spine, Inc. II Jun-02-2010
4 Blackstone Medical, Inc. II May-26-2010
5 Blackstone Medical, Inc. II Jan-26-2008
6 Captiva Spine, Inc II May-23-2012
7 Captiva Spine, Inc II May-14-2012
8 Genesys Orthopedic Systems, LLC II Mar-08-2013
9 Integra LifeSciences Corp. II May-13-2011
10 Medtronic Sofamor Danek USA Inc II Oct-10-2012
11 Medtronic Sofamor Danek USA Inc II Jan-11-2012
12 Medtronic Sofamor Danek USA Inc II Mar-27-2007
13 Stryker Spine II Apr-12-2010
14 Stryker Spine II Nov-24-2009
15 Stryker Spine II Aug-20-2009
16 Stryker Spine III Nov-20-2008
17 Synthes USA HQ, Inc. II Feb-04-2013
18 Theken Spine Llc II Oct-19-2010
19 Zimmer Inc. II Dec-10-2010
20 Zimmer Inc. II Sep-01-2008

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