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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, drill, pneumatic
Regulation Description Pneumatic cranial drill motor.
Product CodeHBB
Regulation Number 882.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
KOMET MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device abrasion from instrument or another object 349
Leak 90
Bent 81
Unintended energization 25
Overheating of device or device component 24
Break 18
Fracture 15
Disassembly 10
Detachment of device component 10
Device inoperable 9
Device operates differently than expected 7
Air leak 5
Fitting problem 3
Unintended movement 3
Mechanical issue 3
Difficult to insert 3
Burst 3
Vibration 3
Material rupture 2
Slippage of device or device component 2
Fluid leak 2
No Information 2
Material deformation 2
Blockage within device or device component 2
Sticking 2
Hole in material 2
Mechanical jam 1
Loss of power 1
Material fragmentation 1
Device-device incompatibility 1
Pressure issue 1
Foreign material present in device 1
Noise, Audible 1
Detachment of device or device component 1
Defective item 1
Component(s), worn 1
Positioning Issue 1
Burn of device or device component 1
Corrosion 1
Unstable 1
Misconnection 1
Device stops intermittently 1
Power source issue 1
Material discolored 1
Migration of device or device component 1
Hose line rupture 1
Physical resistance 1
Metal shedding debris 1
Dislodged or dislocated 1
Melted 1
Unknown (for use when the device problem is not known) 1
Device displays error message 1
Occlusion within device 1
Output below specifications 1
Failure, intermittent 1
Total Device Problems 706

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 1 1 1 0 0 0 0 2 1 2 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Powered Surgical Solutions II Aug-23-2008
2 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II May-04-2016
3 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II Nov-20-2015
4 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II Dec-17-2009
5 Stryker Instruments Div. of Stryker Corporation II Jun-09-2016
6 The Anspach Effort, Inc. II Jun-25-2014
7 The Anspach Effort, Inc. II Jan-09-2014
8 The Anspach Effort, Inc. II Jul-11-2007

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