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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, manual, surgical, general use
Regulation Description Manual surgical instrument for general use.
Product CodeMDM
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
AMERICAN SAFETY
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
DENVER BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
DYNAREX
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 74
Break 66
Peeled 25
Other (for use when an appropriate device code cannot be identified) 18
Difficult to remove 11
Detachment of device component 10
Bent 8
Device, or device fragments remain in patient 7
Tip breakage 7
Device contamination with blood or blood product 7
Connection issue 7
Mechanical jam 7
Fitting problem 7
Scratched material 6
Device-device incompatibility 5
Replace 5
Component falling 5
Material deformation 4
Detachment of device or device component 4
Device operates differently than expected 4
Use of Device Issue 3
Material integrity issue 3
Naturally worn 3
Disassembly 3
Size incorrect for patient 3
Slippage of device or device component 2
Sticking 2
Tears, rips, holes in device, device material 2
Unknown (for use when the device problem is not known) 2
Device damaged prior to use 2
Loose 2
Material fragmentation 2
Material frayed 2
Wire(s), breakage of 2
Device or device component damaged by another device 2
Failure to separate 2
Physical resistance 1
Device or device fragments location unknown 1
Sharp/jagged/rough/etched/scratched 1
Device, removal of (non-implant) 1
Malposition of device 1
Device disinfection or sterilization issue 1
Device Issue 1
Malfunction 1
Failure to align 1
Failure to advance 1
Labeling, missing 1
Split 1
Improper or incorrect procedure or method 1
Solder joint failure 1
Residue after decontamination 1
Dislodged or dislocated 1
Foreign material present in device 1
Torn material 1
No Information 1
Device handling issue 1
Difficult to insert 1
Kinked 1
Displacement 1
Entrapment of device or device component 1
Device expiration issue 1
Flaked 1
Contamination during use 1
Degraded 1
Failure to deploy 1
Accessory incompatible 1
Device Cleaning Issue 1
Mechanical issue 1
Retraction problem 1
Material separation 1
Defective component 1
Component missing 1
Total Device Problems 360

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 0 2 2 1 1 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Aug-16-2010
2 DePuy Orthopaedics, Inc. II Oct-09-2014
3 Merit Medical Systems, Inc. II Dec-14-2009
4 SpineFrontier, Inc. II Aug-08-2013
5 Stryker Instruments Division of Stryker Corporation II Jul-06-2011
6 Stryker Spine II Aug-09-2012
7 Stryker Spine II Jul-08-2010
8 Stryker Spine II Feb-03-2009

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