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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plate, cranioplasty, preformed, non-alterable
Regulation Description Preformed nonalterable cranioplasty plate.
Product CodeGXN
Regulation Number 882.5330
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 3
BIOPLATE, INC.
  SUBSTANTIALLY EQUIVALENT 5
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES
  SUBSTANTIALLY EQUIVALENT 4
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 12
Device operates differently than expected 10
Size incorrect for patient 9
Break 7
Fitting problem 6
Failure to Adhere or Bond 5
Improper or incorrect procedure or method 3
Use of Device Issue 3
No code available 2
Material integrity issue 2
Material deformation 2
No Information 2
Loose or intermittent connection 2
Material Distortion 1
Implant, removal of 1
Difficult to position 1
Normal 1
Unintended movement 1
Electro-magnetic interference (EMI) 1
Device inoperable 1
Fracture 1
Disassembly 1
Explanted 1
Shipping damage or problem 1
Total Device Problems 76

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 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 Synthes (USA) Products LLC II Sep-23-2015

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