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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, penile
Regulation Description Penile rigidity implant.
Product CodeFAE
Regulation Number 876.3630
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 11
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 2
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 5
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 51
No Information 47
Device operates differently than expected 12
Mechanical issue 8
Size incorrect for patient 6
Malposition of device 5
Migration of device or device component 4
Extrusion 4
Fracture 2
Break 2
Crack 1
Noise, Audible 1
Fluid leak 1
Positioning Issue 1
Malfunction 1
Inflation issue 1
Tear, rip or hole in device packaging 1
Material discolored 1
Device inoperable 1
Dislodged or dislocated 1
Explanted 1
Buckled material 1
Degraded 1
Total Device Problems 154

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

Recalls
Manufacturer Recall Class Date Posted
1 American Medical Systems II Apr-03-2007
2 Coloplast Manufacturing US, LLC II Apr-27-2015

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