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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 162
Break 125
Fracture 89
Disassembly 71
Bent 39
Flaked 37
Device operates differently than expected 16
Device displays error message 11
Sticking 11
Device inoperable 9
Temperature issue 8
Leak 5
Other (for use when an appropriate device code cannot be identified) 4
Device abrasion from instrument or another object 4
Mechanical issue 3
Material fragmentation 2
Difficult to insert 2
Unintended energization 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
Dull 2
Detachment of device or device component 2
Improper device output 2
No Information 2
Noise, Audible 2
Material Protrusion 1
Mechanical jam 1
No Known Device Problem 1
Packaging issue 1
Positioning Issue 1
Scratched material 1
Device markings issue 1
Unintended movement 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 652

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 4
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 Sep-16-2016
11 The Anspach Effort, Inc. II Jul-29-2015
12 The Anspach Effort, Inc. II Jun-25-2014
13 The Anspach Effort, Inc. II Jan-15-2014
14 The Anspach Effort, Inc. II Jan-13-2014
15 The Anspach Effort, Inc. II Jan-10-2014
16 The Anspach Effort, Inc. II Jan-09-2014
17 The Anspach Effort, Inc. II Nov-13-2013
18 The Anspach Effort, Inc. II May-24-2013
19 The Anspach Effort, Inc. II Oct-18-2012
20 The Anspach Effort, Inc. II Aug-01-2011
21 The Anspach Effort, Inc. II Oct-28-2009

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