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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device posterior metal/polymer spinal system, fusion
Regulation Description Pedicle screw spinal system.
Definition This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Product CodeNQP
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTERPULSE ORTHOPEDICS, INC.
  SE - WITH LIMITATIONS 1
GLOBUS
  SE - WITH LIMITATIONS 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Implant breakage or physical damage 138
Break 76
Loose 26
Explanted 21
No Information 21
No Known Device Problem 13
Migration of device or device component 6
Replace 6
Implant, removal of 6
Unknown (for use when the device problem is not known) 5
Device remains implanted 5
Fracture 3
Implant, repositioning of 3
Loose or intermittent connection 3
Malfunction 3
Device-device incompatibility 2
No code available 2
Cable break 2
Coagulation in device or device ingredient 1
Collapse 1
Connection error 1
Screw tapper, damaged 1
Disassembly 1
Displacement 1
Material fragmentation 1
Material frayed 1
Device, or device fragments remain in patient 1
Device Issue 1
Internal fixation, revision of 1
Bacterial contamination of device 1
Bent 1
Blockage within device or device component 1
Material rigid or stiff 1
Rupture due to capsulotomy 1
Sticking 1
Tip breakage 1
Device inoperable 1
Screw head(s), incorrect 1
Fitting problem 1
Noise, Audible 1
Torn material 1
Not Applicable 1
Device operates differently than expected 1
Failure to align 1
Defective item 1
Malposition of device 1
Total Device Problems 369

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 2 1 0 1 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Sofamor Danek USA Inc II Sep-11-2008
2 Synthes Spine II Feb-03-2009
3 Synthes USA (HQ), Inc. II Sep-01-2010
4 Zimmer Inc. II Nov-19-2009
5 Zimmer, Inc. II Nov-06-2012

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