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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device injector, vertebroplasty (does not contain cement)
Regulation Description Cement dispenser.
Definition Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Product CodeOAR
Regulation Number 888.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 19
Device operates differently than expected 4
No Known Device Problem 4
Material integrity issue 2
Fracture 2
Leak 2
Device, or device fragments remain in patient 2
Retraction problem 1
Use of Device Issue 1
Material fragmentation 1
Detachment of device component 1
Fluid leak 1
Torn material 1
No code available 1
Total Device Problems 42

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 0 0 0 0 1 2 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jul-03-2012
2 Medtronic Sofamor Danek USA Inc II Jun-03-2017
3 Orthovita, Inc., dBA Stryker Orthobiologics. II May-24-2013
4 Synthes USA HQ, Inc. II Nov-27-2013

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