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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drills, burrs, trephines & accessories (compound, powered)
Regulation Description Powered compound cranial drills, burrs, trephines, and their accessories.
Product CodeHBF
Regulation Number 882.4305
Device Class 2


Premarket Reviews
ManufacturerDecision
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Other (for use when an appropriate device code cannot be identified) 52
Failure to auto stop 34
Use of Device Issue 13
No Known Device Problem 12
Dull 11
Disconnection 3
Fail-safe mechanism issue 3
No code available 3
Break 2
Device Issue 2
Plunge 2
Device operates differently than expected 2
Malfunction 1
No Information 1
Foreign material present in device 1
Device, or device fragments remain in patient 1
Failure to sense 1
Application interface becomes non-functional or program exits abnormally 1
Design/structure problem 1
Flaked 1
Difficult to insert 1
Total Device Problems 148

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

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, Inc. II Jan-11-2012

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