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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
2019 24 24
2020 29 29
2021 26 26
2022 23 23
2023 14 14
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 59 59
Material Fragmentation 13 13
Fracture 12 12
Detachment of Device or Device Component 7 7
Material Separation 6 6
Material Integrity Problem 5 5
Contamination /Decontamination Problem 5 5
Device Fell 4 4
Material Erosion 4 4
Peeled/Delaminated 4 4
Loose or Intermittent Connection 3 3
Compatibility Problem 3 3
Material Twisted/Bent 3 3
Appropriate Term/Code Not Available 3 3
Material Deformation 2 2
Component Missing 2 2
Mechanical Problem 2 2
Difficult to Remove 1 1
Entrapment of Device 1 1
Solder Joint Fracture 1 1
Structural Problem 1 1
Device Slipped 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 59 59
Insufficient Information 16 16
No Known Impact Or Consequence To Patient 16 16
Foreign Body In Patient 14 14
No Consequences Or Impact To Patient 14 14
Hemorrhage/Bleeding 2 2
Patient Problem/Medical Problem 2 2
Device Embedded In Tissue or Plaque 2 2
No Information 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1
Failure of Implant 1 1
Nerve Damage 1 1
Pain 1 1
Deformity/ Disfigurement 1 1
Spinal Cord Injury 1 1
Ambulation Difficulties 1 1
No Patient Involvement 1 1

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