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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
2018 433 433
2019 460 460
2020 466 466
2021 550 550
2022 506 506
2023 206 206

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 942 942
Break 414 414
Failure to Cut 224 224
Unintended Movement 196 196
Scratched Material 192 192
Naturally Worn 169 169
Material Deformation 163 163
Difficult to Advance 114 114
Loose or Intermittent Connection 113 113
Material Twisted/Bent 102 102
Appropriate Term/Code Not Available 81 81
Adverse Event Without Identified Device or Use Problem 79 79
Fracture 63 63
Connection Problem 56 56
Dull, Blunt 50 50
Structural Problem 49 49
Physical Resistance/Sticking 38 38
Component Missing 35 35
Inadequacy of Device Shape and/or Size 33 33
Mechanical Jam 33 33
Device Slipped 29 29
Contamination /Decontamination Problem 28 28
Material Integrity Problem 24 24
Illegible Information 21 21
Crack 18 18
Entrapment of Device 17 17
Device Damaged Prior to Use 17 17
Difficult to Open or Close 16 16
Chemical Problem 15 15
Fitting Problem 15 15
Difficult to Remove 12 12
Bent 10 10
Device Dislodged or Dislocated 7 7
Device Markings/Labelling Problem 6 6
Positioning Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Defective Device 6 6
Insufficient Information 6 6
Difficult to Insert 5 5
Detachment of Device or Device Component 5 5
Device Contamination with Chemical or Other Material 4 4
Device Contaminated During Manufacture or Shipping 4 4
Incomplete or Inadequate Connection 4 4
No Apparent Adverse Event 3 3
Device Damaged by Another Device 3 3
Device Issue 3 3
Use of Device Problem 3 3
Failure to Advance 2 2
Blocked Connection 2 2
Deformation Due to Compressive Stress 2 2
Mechanical Problem 2 2
Off-Label Use 2 2
Corroded 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Operates Differently Than Expected 2 2
Separation Problem 2 2
Failure to Clean Adequately 1 1
Noise, Audible 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Migration 1 1
Output Problem 1 1
Difficult to Open or Remove Packaging Material 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
Sticking 1 1
Misconnection 1 1
Dent in Material 1 1
Failure to Disconnect 1 1
Solder Joint Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1152 1152
No Consequences Or Impact To Patient 1129 1129
No Code Available 169 169
Insufficient Information 111 111
Not Applicable 76 76
Bone Fracture(s) 38 38
No Known Impact Or Consequence To Patient 34 34
Limb Fracture 17 17
Unspecified Tissue Injury 11 11
No Information 11 11
Pain 10 10
Joint Dislocation 7 7
Unspecified Infection 6 6
Joint Laxity 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Foreign Body In Patient 4 4
No Patient Involvement 4 4
Loss of Range of Motion 2 2
Scar Tissue 1 1
Fall 1 1
Fatigue 1 1
Foreign Body Reaction 1 1
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Inadequate Osseointegration 1 1
Device Embedded In Tissue or Plaque 1 1
Distress 1 1
Discomfort 1 1
Deformity/ Disfigurement 1 1
Physical Asymmetry 1 1
Thrombosis/Thrombus 1 1

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