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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 68
Slippage of device or device component 42
Defective item 26
Not Applicable 25
Unintended movement 16
Material disintegration 13
Difficult to deploy 12
Break 10
No Known Device Problem 10
Unstable 8
Unintended head motion 7
Loose or intermittent connection 7
Use of Device Issue 6
Other (for use when an appropriate device code cannot be identified) 6
Device handling issue 6
No code available 5
Material integrity issue 5
Mechanics altered 4
Dislodged or dislocated 4
No Information 4
Difficult to position 4
Product quality issue 3
Material separation 3
Mechanical issue 3
Defective component 3
Crack 3
Detachment of device component 3
Failure to Adhere or Bond 3
Disassembly 3
Improper or incorrect procedure or method 3
Positioning Issue 3
Item contaminated during manufacturing or shipping 2
Detachment of device or device component 2
Disconnection 2
Bent 2
Fracture 2
Component missing 2
Metal shedding debris 2
Sticking 2
Device stops intermittently 1
Failure to align 1
Failure to separate 1
Difficult or delayed activation 1
Migration of device or device component 1
Unintended system motion 1
Output above specifications 1
Failure to service 1
Premature deployment 1
Electrical issue 1
Failure to fold 1
Loose 1
Device maintenance issue 1
Component falling 1
Failure to deploy 1
Device displays error message 1
Foreign material present in device 1
Device packaging compromised 1
Difficult to open or close 1
Maintenance does not comply to manufacturers recommendations 1
Material deformation 1
Material Protrusion 1
Material torqued 1
Pressure issue 1
Total Device Problems 358

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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