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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
Device operates differently than expected 41
Slippage of device or device component 26
Defective item 19
Not Applicable 18
Difficult to deploy 12
No Known Device Problem 10
Unintended movement 10
Break 7
Loose or intermittent connection 7
Other (for use when an appropriate device code cannot be identified) 6
Use of Device Issue 5
Material disintegration 5
No code available 5
Device handling issue 5
Material integrity issue 5
Dislodged or dislocated 4
Unintended head motion 4
Difficult to position 3
Material separation 3
Disassembly 3
Detachment of device component 3
Failure to Adhere or Bond 3
Crack 3
No Information 3
Positioning Issue 3
Mechanics altered 3
Improper or incorrect procedure or method 2
Item contaminated during manufacturing or shipping 2
Fracture 2
Mechanical issue 2
Bent 2
Sticking 2
Product quality issue 2
Defective component 2
Component missing 2
Failure to align 1
Failure to separate 1
Difficult or delayed activation 1
Metal shedding debris 1
Device displays error message 1
Detachment of device or device component 1
Premature deployment 1
Device stops intermittently 1
Failure to service 1
Component falling 1
Disconnection 1
Electrical issue 1
Migration of device or device component 1
Unintended system motion 1
Output above specifications 1
Loose 1
Device maintenance issue 1
Maintenance does not comply to manufacturers recommendations 1
Material deformation 1
Material Protrusion 1
Material torqued 1
Difficult to open or close 1
Pressure issue 1
Total Device Problems 257

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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