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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device osteotome
Product CodeHWM
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 54 54
2020 57 57
2021 73 73
2022 75 75
2023 72 72
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Break 165 165
Failure to Cut 65 65
Material Deformation 55 55
Material Twisted/Bent 27 27
Device-Device Incompatibility 18 18
Fracture 18 18
Naturally Worn 17 17
Scratched Material 12 12
Dull, Blunt 12 12
Material Integrity Problem 7 7
Device Slipped 5 5
Crack 4 4
Use of Device Problem 3 3
Mechanical Jam 3 3
Corroded 3 3
Contamination /Decontamination Problem 3 3
Detachment of Device or Device Component 3 3
Unintended Movement 3 3
Illegible Information 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Mechanical Problem 2 2
Peeled/Delaminated 1 1
Material Separation 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Entrapment of Device 1 1
Device Reprocessing Problem 1 1
Defective Component 1 1
Component Missing 1 1
Structural Problem 1 1
Deformation Due to Compressive Stress 1 1
No Apparent Adverse Event 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 227 227
No Consequences Or Impact To Patient 82 82
Insufficient Information 17 17
No Patient Involvement 10 10
No Known Impact Or Consequence To Patient 4 4
No Code Available 3 3
Foreign Body In Patient 3 3
Bone Fracture(s) 2 2
Perforation 1 1
Limb Fracture 1 1

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