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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 120
Break 71
Peeled 25
Other (for use when an appropriate device code cannot be identified) 18
Difficult to remove 12
Detachment of device component 10
Material deformation 10
Bent 8
Component falling 7
Tip breakage 7
Device, or device fragments remain in patient 7
Fitting problem 7
Mechanical jam 7
Connection issue 7
Device-device incompatibility 7
Device contamination with blood or blood product 7
Scratched material 6
Device operates differently than expected 5
Replace 5
Corrosion 5
Device Cleaning Issue 4
Detachment of device or device component 4
Failure to separate 4
Naturally worn 3
Material integrity issue 3
Material twisted 3
Device or device fragments location unknown 3
Disassembly 3
Use of Device Issue 3
Size incorrect for patient 3
Slippage of device or device component 2
Sticking 2
Tears, rips, holes in device, device material 2
Loose 2
Material fragmentation 2
Material frayed 2
Contamination during use 2
Failure to align 2
Wire(s), breakage of 2
Unknown (for use when the device problem is not known) 2
Device damaged prior to use 2
Device or device component damaged by another device 2
Component missing 2
Dislodged or dislocated 1
Foreign material present in device 1
Physical resistance 1
Device disinfection or sterilization issue 1
Torn material 1
No Information 1
Device handling issue 1
Defective component 1
Device Issue 1
Malfunction 1
Solder joint failure 1
Residue after decontamination 1
Failure to advance 1
Labeling, missing 1
Split 1
Sharp/jagged/rough/etched/scratched 1
Device, removal of (non-implant) 1
Malposition of device 1
Degraded 1
Failure to deploy 1
Accessory incompatible 1
Difficult to insert 1
Kinked 1
Displacement 1
Entrapment of device or device component 1
Device expiration issue 1
Flaked 1
Mechanical issue 1
Difficult to position 1
Retraction problem 1
Material rigid or stiff 1
Material separation 1
Improper or incorrect procedure or method 1
Total Device Problems 443

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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