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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 4
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 356
Leak 105
Bent 81
Overheating of device or device component 45
Unintended energization 28
Break 19
Unintended system motion 18
Noise, Audible 17
Fail-safe mechanism issue 16
Fracture 15
Disassembly 12
Detachment of device component 11
Device inoperable 11
Fluid leak 8
Device operates differently than expected 7
Mechanical issue 6
Air leak 6
Vibration 4
Fitting problem 3
Unintended movement 3
Burst 3
Material rupture 3
Difficult to insert 3
Hole in material 2
Slippage of device or device component 2
Blockage within device or device component 2
No Information 2
Sticking 2
Device stops intermittently 2
Material deformation 2
Mechanical jam 1
Naturally worn 1
Output below specifications 1
Positioning Issue 1
Power source issue 1
Pressure issue 1
Metal shedding debris 1
Device-device incompatibility 1
Dislodged or dislocated 1
Unstable 1
Unknown (for use when the device problem is not known) 1
Physical resistance 1
Defective item 1
Detachment of device or device component 1
Foreign material present in device 1
Maintenance does not comply to manufacturers recommendations 1
Burn of device or device component 1
Component falling 1
Component(s), worn 1
Corrosion 1
Material fragmentation 1
Material discolored 1
Failure, intermittent 1
Smoking 1
Melted 1
Loss of power 1
Device remains activated 1
Difficult to remove 1
Hose line rupture 1
Migration of device or device component 1
Misconnection 1
Occlusion within device 1
Total Device Problems 826

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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