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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spinal vertebral body replacement device
Regulation Description Spinal intervertebral body fixation orthosis.
Product CodeMQP
Regulation Number 888.3060
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 12
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 6
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 8
IMPLEX
  SUBSTANTIALLY EQUIVALENT 8
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SPINAL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 10
LANX
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  1
  SUBSTANTIALLY EQUIVALENT 31
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 6
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 1
OSTEOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 4
PIONEER
  SUBSTANTIALLY EQUIVALENT 3
SCIENT'X
  SUBSTANTIALLY EQUIVALENT 1
SPINAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 5
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 10
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 9
SURGICRAFT CO.
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES
  SUBSTANTIALLY EQUIVALENT 6
THEKEN SPINE
  SUBSTANTIALLY EQUIVALENT 5
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
VERTEBRON, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Break 134
No Known Device Problem 77
Migration of device or device component 41
Implant breakage or physical damage 31
Device remains implanted 19
Implant, removal of 18
Implant, repositioning of 18
Explanted 15
Fracture 15
Device, or device fragments remain in patient 14
Mechanical issue 11
Slippage of device or device component 10
Device operates differently than expected 10
Dislodged or dislocated 9
Malposition of device 9
Detachment of device or device component 8
Collapse 5
Material discolored 5
Detachment of device component 5
Crack 5
Disconnection 4
Loose or intermittent connection 4
Improper or incorrect procedure or method 4
No code available 4
Material deformation 3
Material fragmentation 3
Dislodged 3
Disengaged 2
Fitting problem 2
Malfunction 2
Unintended movement 2
Device markings issue 2
Implant Mobility NOS (Not otherwise specified) 2
Device or device fragments location unknown 2
No Information 2
Device inoperable 1
Deployment issue 1
Difficult to open or close 1
Not Applicable 1
Failure to align 1
Failure to advance 1
Split 1
Defective item 1
Unknown (for use when the device problem is not known) 1
Component missing 1
Loose 1
Markings unclear 1
Normal 1
Difficult to position 1
Replace 1
Size incorrect for patient 1
Component(s), broken 1
Difficult to deploy 1
Failure to deploy 1
Disassembly 1
Failure to discharge 1
Shock, electrical 1
Inflation issue 1
Flaked 1
Fluid leak 1
Foreign material 1
Total Device Problems 526

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Spine II Jan-17-2007
2 Alphatec Spine, Inc. II Dec-31-2008
3 Atlas Spine, Inc. II May-06-2016
4 EBI, L.P. III Sep-22-2009
5 Integra LifeSciences Corp. II May-19-2011
6 Integra LifeSciences Corp. II Mar-02-2011
7 Lucero Medical LLC II Sep-11-2012
8 Lucero Medical LLC II Feb-17-2012
9 Orthofix, Inc II Jan-15-2010
10 Synthes USA (HQ), Inc. II Jun-26-2015
11 Synthes USA (HQ), Inc. I Nov-09-2009
12 Synthes, Inc. II Jun-02-2014
13 TITAN SPINE, LLC II Dec-17-2012

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