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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device holder, head, neurosurgical (skull clamp)
Regulation Description Neurosurgical head holder (skull clamp).
Product CodeHBL
Regulation Number 882.4460
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTEGRA
  SUBSTANTIALLY EQUIVALENT 10
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
MIZUHO
  SUBSTANTIALLY EQUIVALENT 1
Ohio Medical Corporation
  SUBSTANTIALLY EQUIVALENT 7
PRO-MED INSTRUMENTS GMBH
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR TECHNOLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Slippage of device or device component 21
Device operates differently than expected 20
Defective item 14
Difficult to deploy 12
Not Applicable 10
No Known Device Problem 8
Break 7
Other (for use when an appropriate device code cannot be identified) 6
Loose or intermittent connection 6
Unintended movement 5
Device handling issue 5
Unintended head motion 4
Dislodged or dislocated 4
No code available 3
Disassembly 3
Use of Device Issue 3
Crack 3
Difficult to position 3
No Information 3
Mechanics altered 3
Material separation 3
Sticking 2
Detachment of device component 2
Positioning Issue 2
Mechanical issue 2
Component missing 2
Bent 2
Failure to Adhere or Bond 2
Improper or incorrect procedure or method 2
Defective component 1
Product quality issue 1
Failure to service 1
Device stops intermittently 1
Material disintegration 1
Migration of device or device component 1
Difficult to open or close 1
Electrical issue 1
Unintended system motion 1
Output above specifications 1
Failure to align 1
Detachment of device or device component 1
Difficult or delayed activation 1
Component falling 1
Disconnection 1
Loose 1
Device maintenance issue 1
Pressure issue 1
Material Protrusion 1
Material torqued 1
Total Device Problems 182

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

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015
2 Integra LifeSciences Corp. II Nov-13-2013
3 Integra LifeSciences Corporation II Dec-19-2012

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