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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 9
IMPLEX
  SUBSTANTIALLY EQUIVALENT 8
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SPINAL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
INTERPORE CROSS
  SUBSTANTIALLY EQUIVALENT 10
K2M
  SUBSTANTIALLY EQUIVALENT 2
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 160
No Known Device Problem 108
Migration of device or device component 83
Implant breakage or physical damage 31
Not Applicable 21
Device remains implanted 19
Fracture 18
Implant, removal of 18
Implant, repositioning of 18
Explanted 15
Device, or device fragments remain in patient 14
Device operates differently than expected 14
Unintended movement 13
Slippage of device or device component 13
Mechanical issue 13
Detachment of device or device component 12
Dislodged or dislocated 11
Malposition of device 9
Collapse 7
Detachment of device component 6
Loose or intermittent connection 6
No code available 6
Crack 5
Material discolored 5
Disconnection 4
Material fragmentation 4
Improper or incorrect procedure or method 4
Material deformation 4
No Information 3
Size incorrect for patient 3
Device markings issue 3
Dislodged 3
Disengaged 2
Fitting problem 2
Use of Device Issue 2
Implant Mobility NOS (Not otherwise specified) 2
Malfunction 2
Material integrity issue 2
Device or device fragments location unknown 2
Positioning Issue 2
Torn material 1
Difficult to open or close 1
Structural problem 1
Failure to align 1
Failure to advance 1
Split 1
Defective item 1
Deployment issue 1
Unknown (for use when the device problem is not known) 1
Component missing 1
Device inoperable 1
Unstable 1
Replace 1
Loose 1
Markings unclear 1
Loss of or failure to bond 1
Normal 1
Difficult to position 1
Device Difficult to Setup or Prepare 1
Component(s), broken 1
Difficult to deploy 1
Failure to deploy 1
Disassembly 1
Failure to discharge 1
Shock, electrical 1
Device expiration issue 1
Inflation issue 1
Flaked 1
Fluid leak 1
Foreign material 1
Total Device Problems 699

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 1 0 0 0 0 0 0 0 0
Class II 1 1 0 1 2 3 0 1 1 1 1
Class III 0 0 1 0 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 Eden Spine Europe SA II May-12-2017
6 Integra LifeSciences Corp. II May-19-2011
7 Integra LifeSciences Corp. II Mar-02-2011
8 Lucero Medical LLC II Sep-11-2012
9 Lucero Medical LLC II Feb-17-2012
10 Orthofix, Inc II Jan-15-2010
11 Synthes USA (HQ), Inc. II Jun-26-2015
12 Synthes USA (HQ), Inc. I Nov-09-2009
13 Synthes, Inc. II Jun-02-2014
14 TITAN SPINE, LLC II Dec-17-2012

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