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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device broach
Product CodeHTQ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2017 225 225
2018 433 433
2019 460 460
2020 466 466
2021 550 550
2022 154 154

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 696 696
Break 401 401
Scratched Material 160 160
Appropriate Term/Code Not Available 160 160
Failure to Cut 143 143
Unintended Movement 135 135
Material Deformation 130 130
Loose or Intermittent Connection 128 128
Naturally Worn 105 105
Material Twisted/Bent 102 102
Connection Problem 82 82
Adverse Event Without Identified Device or Use Problem 65 65
Fracture 63 63
Difficult to Advance 52 52
Dull, Blunt 51 51
Physical Resistance/Sticking 38 38
Component Missing 35 35
Inadequacy of Device Shape and/or Size 34 34
Structural Problem 34 34
Device Slipped 30 30
Contamination /Decontamination Problem 27 27
Mechanical Jam 25 25
Crack 20 20
Illegible Information 19 19
Fitting Problem 18 18
Bent 16 16
Entrapment of Device 14 14
Difficult to Remove 13 13
Device Damaged Prior to Use 12 12
Material Integrity Problem 12 12
Insufficient Information 12 12
Difficult to Open or Close 10 10
Chemical Problem 8 8
Device Markings/Labelling Problem 6 6
Positioning Problem 6 6
Defective Device 6 6
Mechanical Problem 6 6
Difficult to Insert 5 5
Device Dislodged or Dislocated 5 5
Device Contamination with Chemical or Other Material 4 4
Device Operates Differently Than Expected 4 4
Incomplete or Inadequate Connection 4 4
Detachment of Device or Device Component 3 3
Device Issue 3 3
Misconnection 3 3
Use of Device Problem 3 3
Blocked Connection 2 2
Deformation Due to Compressive Stress 2 2
Failure to Advance 2 2
Corroded 2 2
Disassembly 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Damaged by Another Device 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Separation Problem 2 2
Failure to Clean Adequately 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Migration 1 1
Compatibility Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Material Discolored 1 1
Material Disintegration 1 1
Positioning Failure 1 1
Backflow 1 1
Loss of or Failure to Bond 1 1
Difficult To Position 1 1
Off-Label Use 1 1
Material Frayed 1 1
Dent in Material 1 1
Failure to Disconnect 1 1
Sticking 1 1
Solder Joint Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1188 1188
No Clinical Signs, Symptoms or Conditions 641 641
No Code Available 172 172
No Information 131 131
No Known Impact Or Consequence To Patient 94 94
Insufficient Information 84 84
Not Applicable 77 77
Bone Fracture(s) 36 36
Limb Fracture 10 10
Pain 7 7
No Patient Involvement 6 6
Joint Dislocation 5 5
Unspecified Tissue Injury 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Joint Laxity 3 3
Unspecified Infection 3 3
Hip Fracture 2 2
Discomfort 1 1
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Thrombosis/Thrombus 1 1
Inadequate Osseointegration 1 1
Device Embedded In Tissue or Plaque 1 1

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