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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intervertebral fusion device with bone graft, solid-sphere, lumbar
Definition Intended to be inserted between the vertebral bodies into the disc space from l3 to s1 to provide stabilization and to help promote intervertebral body fusion. To be used with bone graft, for holding bone parts in alignment while they heal. Not intended for use in motion-sparing, non-fusion procedures, helps promote intervertebral body fusion.
Product CodeNVR
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BIOMET
  SE - WITH LIMITATIONS 1
LIFE SPINE
  SE - WITH LIMITATIONS 1
MEDTRONIC, INC.
  SE - WITH LIMITATIONS 2

Device Problems
Implant, repositioning of 4
Malposition of device 2
Break 2
Implant, removal of 2
Unknown (for use when the device problem is not known) 1
No Known Device Problem 1
No Information 1
Total Device Problems 13

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 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Sofamor Danek USA Inc II Dec-22-2007

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