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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 157
Break 78
Peeled 25
Other (for use when an appropriate device code cannot be identified) 18
Detachment of device component 14
Difficult to remove 12
Material twisted 12
Material deformation 10
Bent 9
Device-device incompatibility 8
Fitting problem 8
Mechanical jam 8
Device, or device fragments remain in patient 7
Device contamination with blood or blood product 7
Connection issue 7
Component falling 7
Crack 7
Tip breakage 7
Corrosion 6
Scratched material 6
Torn material 5
Replace 5
Device Cleaning Issue 4
Disassembly 4
Failure to separate 4
Detachment of device or device component 4
Material integrity issue 4
Device operates differently than expected 4
Device or device fragments location unknown 3
Component missing 3
Difficult to insert 3
Use of Device Issue 3
Size incorrect for patient 3
Naturally worn 3
Split 3
No Information 2
Slippage of device or device component 2
Sticking 2
Tears, rips, holes in device, device material 2
Metal shedding debris 2
Loose 2
Material fragmentation 2
Material frayed 2
Contamination during use 2
Unknown (for use when the device problem is not known) 2
Device damaged prior to use 2
Failure to align 2
Wire(s), breakage of 2
Device or device component damaged by another device 2
Difficult to open or close 2
Dislodged or dislocated 1
Foreign material present in device 1
Sharp/jagged/rough/etched/scratched 1
Device, removal of (non-implant) 1
Malposition of device 1
Device disinfection or sterilization issue 1
Device misassembled during manufacturing or shipping 1
Device Issue 1
Malfunction 1
Solder joint failure 1
Residue after decontamination 1
Failure to advance 1
Labeling, missing 1
Physical resistance 1
Defective component 1
Degraded 1
Failure to deploy 1
Accessory incompatible 1
Kinked 1
Displacement 1
Entrapment of device or device component 1
Device expiration issue 1
Flaked 1
Mechanical issue 1
Melted 1
Difficult to position 1
Retraction problem 1
Material rigid or stiff 1
Material separation 1
Improper or incorrect procedure or method 1
No code available 1
Device handling issue 1
Positioning Issue 1
Total Device Problems 531

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 0 2 2 1 1 1 1 0 0 1
Class III 0 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 Exactech, Inc. II Aug-11-2017
4 Merit Medical Systems, Inc. II Dec-14-2009
5 SpineFrontier, Inc. II Aug-08-2013
6 Stryker Instruments Division of Stryker Corporation II Jul-06-2011
7 Stryker Spine II Aug-09-2012
8 Stryker Spine II Jul-08-2010
9 Stryker Spine II Feb-03-2009

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