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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 284
Break 141
Flaked 121
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
Device abrasion from instrument or another object 4
Noise, Audible 4
Other (for use when an appropriate device code cannot be identified) 4
Smoking 3
Mechanical issue 3
Material fragmentation 3
Difficult to insert 2
Unintended energization 2
Detachment of device component 2
Device remains activated 2
Self-activation or keying 2
Material separation 2
Vibration 2
Metal shedding debris 2
Defective component 2
Component missing 2
Dull 2
Improper device output 2
No Information 2
Detachment of device or device component 2
Device markings issue 1
Unintended movement 1
Material Protrusion 1
Mechanical jam 1
Naturally worn 1
No Known Device Problem 1
Packaging issue 1
Positioning Issue 1
Scratched material 1
Ambient noise issue 1
Disinfection or Sterilization Issue at User Location 1
Device Issue 1
Fitting problem 1
Unstable 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
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
Loose or intermittent connection 1
Total Device Problems 908

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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