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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 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 898 898
Break 399 399
Failure to Cut 210 210
Scratched Material 191 191
Unintended Movement 189 189
Naturally Worn 162 162
Material Deformation 155 155
Difficult to Advance 113 113
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 76 76
Fracture 58 58
Connection Problem 56 56
Dull, Blunt 50 50
Structural Problem 48 48
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
Difficult to Open or Close 16 16
Fitting Problem 15 15
Device Damaged Prior to Use 14 14
Chemical Problem 14 14
Difficult to Remove 12 12
Bent 10 10
Tear, Rip or Hole in Device Packaging 6 6
Defective Device 6 6
Device Markings/Labelling Problem 6 6
Device Dislodged or Dislocated 6 6
Positioning Problem 6 6
Insufficient Information 6 6
Detachment of Device or Device Component 5 5
Difficult to Insert 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
Use of Device Problem 3 3
Device Issue 3 3
Blocked Connection 2 2
Deformation Due to Compressive Stress 2 2
Failure to Advance 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 Consequences Or Impact To Patient 1129 1129
No Clinical Signs, Symptoms or Conditions 1078 1078
No Code Available 169 169
Insufficient Information 104 104
Not Applicable 76 76
Bone Fracture(s) 38 38
No Known Impact Or Consequence To Patient 34 34
Limb Fracture 16 16
No Information 11 11
Unspecified Tissue Injury 10 10
Pain 8 8
Joint Dislocation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Foreign Body In Patient 4 4
Joint Laxity 4 4
No Patient Involvement 4 4
Unspecified Infection 4 4
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Distress 1 1
Discomfort 1 1
Deformity/ Disfigurement 1 1
Inadequate Osseointegration 1 1
Scar Tissue 1 1
Device Embedded In Tissue or Plaque 1 1
Thrombosis/Thrombus 1 1

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