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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 140
Break 71
Peeled 25
Other (for use when an appropriate device code cannot be identified) 18
Material twisted 12
Difficult to remove 12
Detachment of device component 11
Material deformation 10
Bent 8
Component falling 7
Tip breakage 7
Mechanical jam 7
Device-device incompatibility 7
Connection issue 7
Device, or device fragments remain in patient 7
Fitting problem 7
Device contamination with blood or blood product 7
Corrosion 6
Scratched material 6
Replace 5
Device operates differently than expected 5
Material integrity issue 5
Detachment of device or device component 4
Failure to separate 4
Device Cleaning Issue 4
Disassembly 3
Use of Device Issue 3
Size incorrect for patient 3
Device or device fragments location unknown 3
Naturally worn 3
Device or device component damaged by another device 2
Wire(s), breakage of 2
Failure to align 2
Unknown (for use when the device problem is not known) 2
Device damaged prior to use 2
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
Component missing 2
Torn material 1
No Information 1
Device handling issue 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
Metal shedding debris 1
Improper or incorrect procedure or method 1
Defective component 1
Solder joint failure 1
Residue after decontamination 1
Failure to advance 1
Labeling, missing 1
Split 1
Device Issue 1
Malfunction 1
Physical resistance 1
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
Total Device Problems 478

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 0
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 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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