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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 58
Slippage of device or device component 35
Defective item 26
Not Applicable 23
Unintended movement 14
Material disintegration 13
Difficult to deploy 12
No Known Device Problem 10
Break 8
Loose or intermittent connection 7
Other (for use when an appropriate device code cannot be identified) 6
Device handling issue 6
Use of Device Issue 6
No code available 5
Material integrity issue 5
Unintended head motion 5
Unstable 4
Dislodged or dislocated 4
Disassembly 3
Product quality issue 3
Defective component 3
Improper or incorrect procedure or method 3
Failure to Adhere or Bond 3
Crack 3
No Information 3
Difficult to position 3
Positioning Issue 3
Mechanics altered 3
Material separation 3
Detachment of device component 3
Sticking 2
Item contaminated during manufacturing or shipping 2
Mechanical issue 2
Fracture 2
Bent 2
Component missing 2
Maintenance does not comply to manufacturers recommendations 1
Metal shedding debris 1
Difficult to open or close 1
Device displays error message 1
Failure to fold 1
Output above specifications 1
Unintended system motion 1
Electrical issue 1
Migration of device or device component 1
Device stops intermittently 1
Failure to service 1
Failure to align 1
Premature deployment 1
Detachment of device or device component 1
Difficult or delayed activation 1
Component falling 1
Disconnection 1
Device maintenance issue 1
Pressure issue 1
Foreign material present in device 1
Loose 1
Material deformation 1
Material torqued 1
Material Protrusion 1
Failure to separate 1
Total Device Problems 320

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 1 1 0 1 0 0
Class III 0 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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