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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 61
Slippage of device or device component 40
Defective item 26
Not Applicable 23
Unintended movement 16
Material disintegration 13
Difficult to deploy 12
No Known Device Problem 10
Break 9
Unstable 9
Loose or intermittent connection 7
Use of Device Issue 6
Unintended head motion 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
Positioning Issue 3
No Information 3
Defective component 3
Improper or incorrect procedure or method 3
Difficult to position 3
Product quality issue 3
Material separation 3
Detachment of device component 3
Failure to Adhere or Bond 3
Disassembly 3
Crack 3
Fracture 2
Mechanical issue 2
Bent 2
Sticking 2
Metal shedding debris 2
Component missing 2
Detachment of device or device component 2
Item contaminated during manufacturing or shipping 2
Maintenance does not comply to manufacturers recommendations 1
Material deformation 1
Foreign material present in device 1
Device displays error message 1
Device packaging compromised 1
Difficult to open or close 1
Material Protrusion 1
Material torqued 1
Pressure issue 1
Failure to align 1
Failure to separate 1
Difficult or delayed activation 1
Device stops intermittently 1
Failure to service 1
Premature deployment 1
Loose 1
Device maintenance issue 1
Component falling 1
Disconnection 1
Failure to deploy 1
Migration of device or device component 1
Unintended system motion 1
Output above specifications 1
Electrical issue 1
Failure to fold 1
Total Device Problems 342

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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