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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device external mandibular fixator and/or distractor
Regulation Description Bone plate.
Product CodeMQN
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 11
MACROPORE BIOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
NEWMEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 7
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 13
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Break 24
Device operates differently than expected 16
No Known Device Problem 10
Failure to Adhere or Bond 4
Difficult to advance 3
Dislodged or dislocated 3
Mechanical jam 2
Bent 2
Material fragmentation 2
Loose or intermittent connection 2
Migration of device or device component 2
Difficult to remove 1
Fitting problem 1
Device damaged prior to use 1
Detachment of device or device component 1
Detachment of device component 1
Positioning Issue 1
Unintended movement 1
No code available 1
Total Device Problems 78

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

Recalls
Manufacturer Recall Class Date Posted
1 Synthes USA HQ, Inc. II Jul-12-2013
2 Synthes, Inc. II Jan-23-2015
3 Synthes, Inc. I Aug-20-2014

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