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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rongeur
Product CodeHTX
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2018 24 24
2019 24 24
2020 29 29
2021 26 26
2022 23 23
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 64 64
Fracture 17 17
Material Fragmentation 10 10
Detachment of Device or Device Component 7 7
Material Separation 6 6
Material Integrity Problem 6 6
Device Fell 4 4
Peeled/Delaminated 4 4
Component Missing 4 4
Material Erosion 4 4
Contamination /Decontamination Problem 4 4
Loose or Intermittent Connection 3 3
Mechanical Problem 3 3
Appropriate Term/Code Not Available 3 3
Compatibility Problem 3 3
Material Twisted/Bent 3 3
Bent 2 2
Material Deformation 2 2
Solder Joint Fracture 1 1
Device Operates Differently Than Expected 1 1
Difficult to Remove 1 1
Device Dislodged or Dislocated 1 1
Device Slipped 1 1
Structural Problem 1 1
Failure to Cut 1 1
Delivered as Unsterile Product 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
No Known Impact Or Consequence To Patient 30 30
No Consequences Or Impact To Patient 17 17
Insufficient Information 15 15
Foreign Body In Patient 12 12
No Patient Involvement 5 5
No Code Available 3 3
Patient Problem/Medical Problem 2 2
No Information 2 2
Hemorrhage/Bleeding 2 2
Device Embedded In Tissue or Plaque 2 2
Nerve Damage 1 1
Pain 1 1
Deformity/ Disfigurement 1 1
Ambulation Difficulties 1 1
Failure of Implant 1 1
Unspecified Tissue Injury 1 1
Spinal Cord Injury 1 1

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