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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drills, burrs, trephines & accessories (simple, powered)
Regulation Description Powered simple cranial drills, burrs, trephines, and their accessories.
Product CodeHBE
Regulation Number 882.4310
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
KOMET MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
MICROAIRE
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 6
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of device or device component 141
Break 117
Fracture 84
Disassembly 60
Bent 35
Flaked 19
Device operates differently than expected 16
Sticking 11
Device inoperable 9
Temperature issue 8
Device displays error message 7
Leak 5
Device abrasion from instrument or another object 4
Other (for use when an appropriate device code cannot be identified) 4
Mechanical issue 3
Material fragmentation 2
Difficult to insert 2
Detachment of device component 2
Defective component 2
Component missing 2
Vibration 2
Metal shedding debris 2
Device remains activated 2
Self-activation or keying 2
Material separation 2
Smoking 2
Detachment of device or device component 2
Dull 2
Noise, Audible 2
Improper device output 2
Material Protrusion 1
Mechanical jam 1
No Known Device Problem 1
Packaging issue 1
Positioning Issue 1
Scratched material 1
Unintended movement 1
No Information 1
Device markings issue 1
Ambient noise issue 1
Disinfection or Sterilization Issue at User Location 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Loss of power 1
Failure to power-up 1
Program, failure to 1
Fitting problem 1
Unstable 1
Device Issue 1
Component falling 1
Blockage within device or device component 1
Burn of device or device component 1
Charred 1
Component(s), broken 1
Device alarm system issue 1
Total Device Problems 578

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 2 1 2 1 2 6 2 3
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, Inc. II Dec-16-2009
2 EXP Pharmaceutical Services Corp II Jul-24-2015
3 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution II Jun-28-2016
4 Stryker Instruments Div. of Stryker Corporation II Jul-19-2016
5 Stryker Instruments Div. of Stryker Corporation II Jul-14-2016
6 Stryker Instruments Div. of Stryker Corporation II Jun-11-2014
7 Stryker Instruments Div. of Stryker Corporation II Jan-11-2010
8 Stryker Instruments Div. of Stryker Corporation II Apr-22-2008
9 Stryker Instruments Division of Stryker Corporation II Feb-14-2011
10 The Anspach Effort, Inc. II Jul-29-2015
11 The Anspach Effort, Inc. II Jun-25-2014
12 The Anspach Effort, Inc. II Jan-15-2014
13 The Anspach Effort, Inc. II Jan-13-2014
14 The Anspach Effort, Inc. II Jan-10-2014
15 The Anspach Effort, Inc. II Jan-09-2014
16 The Anspach Effort, Inc. II Nov-13-2013
17 The Anspach Effort, Inc. II May-24-2013
18 The Anspach Effort, Inc. II Oct-18-2012
19 The Anspach Effort, Inc. II Aug-01-2011
20 The Anspach Effort, Inc. II Oct-28-2009

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