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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 371
Flaked 199
Break 157
Fracture 106
Disassembly 81
Bent 49
Device operates differently than expected 16
Device displays error message 13
Device inoperable 12
Sticking 11
Mechanical issue 9
Temperature issue 8
Leak 7
Vibration 5
Other (for use when an appropriate device code cannot be identified) 4
Noise, Audible 4
Device abrasion from instrument or another object 4
Detachment of device component 4
Material fragmentation 3
Smoking 3
Self-activation or keying 3
Material separation 2
Device remains activated 2
Difficult to position 2
Difficult to insert 2
Unintended energization 2
Dull 2
No Information 2
Detachment of device or device component 2
Defective component 2
Component missing 2
Metal shedding debris 2
Improper device output 2
Material Protrusion 1
Mechanical jam 1
Naturally worn 1
No Known Device Problem 1
Packaging issue 1
Positioning Issue 1
Scratched material 1
Fitting problem 1
Unstable 1
Device Issue 1
Device markings issue 1
Unintended movement 1
Ambient noise issue 1
Biocompatibility issue 1
Disinfection or Sterilization Issue at User Location 1
Device alarm system issue 1
Material discolored 1
Component falling 1
Blockage within device or device component 1
Burn of device or device component 1
Charred 1
Component(s), broken 1
Loss of power 1
Failure to power-up 1
Program, failure to 1
Misconnection 1
Unintended system motion 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Loose or intermittent connection 1
Total Device Problems 1123

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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