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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 90
Slippage of device or device component 70
Not Applicable 50
No Information 32
Defective item 26
Unintended movement 25
Break 15
Material disintegration 13
Difficult to deploy 12
No Known Device Problem 12
Positioning Issue 12
Loose or intermittent connection 10
Mechanical issue 10
Unintended head motion 8
Unstable 8
Use of Device Issue 7
Device handling issue 7
Material integrity issue 6
Other (for use when an appropriate device code cannot be identified) 6
Product quality issue 5
No code available 5
Dislodged or dislocated 5
Mechanics altered 4
Difficult to position 4
Detachment of device component 4
Failure to Adhere or Bond 3
Disassembly 3
Crack 3
Defective component 3
Component missing 3
Material separation 3
Improper or incorrect procedure or method 3
Detachment of device or device component 2
Metal shedding debris 2
Item contaminated during manufacturing or shipping 2
Failure to service 2
Sticking 2
Device Issue 2
Fracture 2
Disconnection 2
Bent 2
Component falling 1
Failure to deploy 1
Material fragmentation 1
Electrical issue 1
Failure to fold 1
Loose 1
Device maintenance issue 1
Failure to align 1
Failure to separate 1
Difficult or delayed activation 1
Device stops intermittently 1
Premature deployment 1
Material rigid or stiff 1
Migration of device or device component 1
Unintended system motion 1
Output above specifications 1
Maintenance does not comply to manufacturers recommendations 1
Material deformation 1
Foreign material present in device 1
Pressure issue 1
Torn material 1
Device displays error message 1
Device packaging compromised 1
Difficult to open or close 1
Material Protrusion 1
Material torqued 1
Total Device Problems 511

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

Recalls
Manufacturer Recall Class Date Posted
1 Deerfield Imaging II Sep-22-2017
2 EXP Pharmaceutical Services Corp II Jul-24-2015
3 Integra LifeSciences Corp. II Nov-13-2013
4 Integra LifeSciences Corporation II Dec-19-2012

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