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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device broach
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTQ
Regulation Number 888.4540
Device Class 1

Device Problems
Device-Device Incompatibility 282
Break 232
Appropriate Term/Code Not Available 164
Loose or Intermittent Connection 108
Scratched Material 91
Connection Problem 80
Naturally Worn 78
Unintended Movement 52
Material Deformation 50
Fracture 35
Component Missing 34
Material Twisted / Bent 31
Fitting Problem 21
Bent 20
Dull, Blunt 18
Insufficient Information 16
Crack 15
Physical Resistance / Sticking 14
Mechanical Problem 13
Inadequacy of Device Shape and/or Size 11
Adverse Event Without Identified Device or Use Problem 11
Device Slipped 10
Mechanical Jam 9
Difficult to Remove 8
Difficult to Insert 5
Entrapment of Device 4
Incomplete or Inadequate Connection 4
Misconnection 4
Device Contamination with Chemical or Other Material 4
Positioning Problem 4
Device Issue 4
Defective Device 3
Deformation Due to Compressive Stress 2
Blocked Connection 2
Disassembly 2
Difficult to Open or Close 2
Device Damaged Prior to Use 2
Structural Problem 2
Separation Problem 2
Detachment of Device or device Component 1
Solder Joint Fracture 1
Manufacturing, Packaging or Shipping Problem 1
Migration 1
Difficult To Position 1
Positioning Failure 1
Material Disintegration 1
Failure to Advance 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Compatibility Problem 1
Material Integrity Problem 1
Failure to Clean Adequately 1
Failure to Disconnect 1
Loss of or Failure to Bond 1
Total Device Problems 1463

Recalls
Manufacturer Recall Class Date Posted
1 Greatbatch Medical II May-09-2017

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