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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
BIOTEX, INC.
  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 295
Break 149
Flaked 124
Fracture 97
Disassembly 77
Bent 47
Device operates differently than expected 16
Device displays error message 13
Device inoperable 12
Sticking 11
Temperature issue 8
Leak 6
Mechanical issue 5
Other (for use when an appropriate device code cannot be identified) 4
Noise, Audible 4
Device abrasion from instrument or another object 4
Smoking 3
Vibration 3
Material fragmentation 3
Material separation 2
Detachment of device component 2
Difficult to position 2
No Information 2
Detachment of device or device component 2
Difficult to insert 2
Dull 2
Improper device output 2
Defective component 2
Component missing 2
Metal shedding debris 2
Self-activation or keying 2
Unintended energization 2
Device remains activated 2
No Known Device Problem 1
Disinfection or Sterilization Issue at User Location 1
Unstable 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Device markings issue 1
Device alarm system issue 1
Loose or intermittent connection 1
Positioning Issue 1
Burn of device or device component 1
Component falling 1
Ambient noise issue 1
Scratched material 1
Naturally worn 1
Component(s), broken 1
Charred 1
Packaging issue 1
Program, failure to 1
Fitting problem 1
Blockage within device or device component 1
Unintended movement 1
Material Protrusion 1
Failure to power-up 1
Device Issue 1
Mechanical jam 1
Loss of power 1
Total Device Problems 935

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 1 2 1 2 1 2 6 2 5 0
Class III 0 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 Dec-21-2016
5 Stryker Instruments Div. of Stryker Corporation II Jul-19-2016
6 Stryker Instruments Div. of Stryker Corporation II Jul-14-2016
7 Stryker Instruments Div. of Stryker Corporation II Jun-11-2014
8 Stryker Instruments Div. of Stryker Corporation II Jan-11-2010
9 Stryker Instruments Div. of Stryker Corporation II Apr-22-2008
10 Stryker Instruments Division of Stryker Corporation II Feb-14-2011
11 The Anspach Effort, Inc. II Sep-16-2016
12 The Anspach Effort, Inc. II Jul-29-2015
13 The Anspach Effort, Inc. II Jun-25-2014
14 The Anspach Effort, Inc. II Jan-15-2014
15 The Anspach Effort, Inc. II Jan-13-2014
16 The Anspach Effort, Inc. II Jan-10-2014
17 The Anspach Effort, Inc. II Jan-09-2014
18 The Anspach Effort, Inc. II Nov-13-2013
19 The Anspach Effort, Inc. II May-24-2013
20 The Anspach Effort, Inc. II Oct-18-2012
21 The Anspach Effort, Inc. II Aug-01-2011
22 The Anspach Effort, Inc. II Oct-28-2009

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