• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 56
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
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
Unintended head motion 5
Unstable 4
Dislodged or dislocated 4
No Information 3
Positioning Issue 3
Improper or incorrect procedure or method 3
Mechanics altered 3
Difficult to position 3
Product quality issue 3
Material separation 3
Defective component 3
Crack 3
Detachment of device component 3
Failure to Adhere or Bond 3
Disassembly 3
Bent 2
Fracture 2
Mechanical issue 2
Component missing 2
Sticking 2
Item contaminated during manufacturing or shipping 2
Maintenance does not comply to manufacturers recommendations 1
Material deformation 1
Material Protrusion 1
Material torqued 1
Foreign material present in device 1
Difficult to open or close 1
Pressure issue 1
Device stops intermittently 1
Failure to service 1
Premature deployment 1
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
Migration of device or device component 1
Unintended system motion 1
Output above specifications 1
Loose 1
Device maintenance issue 1
Component falling 1
Disconnection 1
Electrical issue 1
Failure to fold 1
Total Device Problems 318

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

-
-