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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
2019 460 460
2020 466 466
2021 550 550
2022 506 506
2023 586 586
2024 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 1131 1131
Break 454 454
Unintended Movement 246 246
Failure to Cut 238 238
Scratched Material 177 177
Material Deformation 169 169
Naturally Worn 132 132
Difficult to Advance 115 115
Material Twisted/Bent 100 100
Adverse Event Without Identified Device or Use Problem 78 78
Structural Problem 64 64
Loose or Intermittent Connection 61 61
Fracture 59 59
Dull, Blunt 50 50
Device Damaged Prior to Use 40 40
Physical Resistance/Sticking 36 36
Mechanical Jam 34 34
Contamination /Decontamination Problem 30 30
Device Slipped 29 29
Material Integrity Problem 28 28
Inadequacy of Device Shape and/or Size 27 27
No Apparent Adverse Event 25 25
Connection Problem 24 24
Chemical Problem 23 23
Illegible Information 21 21
Difficult to Open or Close 17 17
Entrapment of Device 16 16
Appropriate Term/Code Not Available 15 15
Fitting Problem 13 13
Component Missing 11 11
Crack 10 10
Detachment of Device or Device Component 9 9
Difficult to Remove 8 8
Device Dislodged or Dislocated 8 8
Positioning Problem 6 6
Device Markings/Labelling Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Device Contaminated During Manufacture or Shipping 5 5
Device Contamination with Chemical or Other Material 4 4
Defective Device 4 4
Off-Label Use 4 4
Corroded 4 4
Use of Device Problem 3 3
Difficult to Insert 3 3
Device Damaged by Another Device 3 3
Failure to Advance 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Insufficient Information 2 2
Incomplete or Inadequate Connection 2 2
Failure to Clean Adequately 1 1
Noise, Audible 1 1
Migration 1 1
Output Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Mechanical Problem 1 1
Backflow 1 1
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
Material Discolored 1 1
Material Frayed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1510 1510
No Consequences Or Impact To Patient 731 731
Insufficient Information 187 187
No Code Available 143 143
Not Applicable 57 57
Bone Fracture(s) 35 35
No Known Impact Or Consequence To Patient 27 27
Limb Fracture 19 19
Unspecified Tissue Injury 12 12
Pain 10 10
No Information 9 9
Unspecified Infection 8 8
Joint Dislocation 8 8
Joint Laxity 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
No Patient Involvement 4 4
Foreign Body In Patient 3 3
Loss of Range of Motion 2 2
Scar Tissue 1 1
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Low Blood Pressure/ Hypotension 1 1
Fall 1 1
Fatigue 1 1
Foreign Body Reaction 1 1
Inadequate Osseointegration 1 1
Distress 1 1
Discomfort 1 1
Deformity/ Disfigurement 1 1
Physical Asymmetry 1 1
Thrombosis/Thrombus 1 1

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