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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rasp
Product CodeHTR
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 13 13
2020 7 7
2021 7 7
2022 15 15
2023 14 14
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 13 13
Material Integrity Problem 13 13
Break 12 12
Fracture 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Naturally Worn 5 5
Contamination /Decontamination Problem 4 4
Material Fragmentation 3 3
Device-Device Incompatibility 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Insufficient Information 1 1
Inadequacy of Device Shape and/or Size 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
No Consequences Or Impact To Patient 9 9
Unspecified Infection 4 4
Bone Fracture(s) 3 3
Insufficient Information 3 3
No Information 2 2
No Code Available 1 1
Embolism/Embolus 1 1
Unspecified Tissue Injury 1 1
Failure of Implant 1 1
Necrosis 1 1
Cyst(s) 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1

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