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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
2020 57 57
2021 73 73
2022 75 75
2023 72 72
2024 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Break 184 184
Failure to Cut 83 83
Material Deformation 55 55
Fracture 23 23
Material Integrity Problem 20 20
Device-Device Incompatibility 18 18
Material Twisted/Bent 17 17
Scratched Material 15 15
Naturally Worn 15 15
Contamination /Decontamination Problem 11 11
Device Slipped 5 5
Crack 4 4
Use of Device Problem 4 4
Dull, Blunt 4 4
Detachment of Device or Device Component 3 3
Illegible Information 3 3
Corroded 3 3
Mechanical Jam 3 3
Mechanical Problem 2 2
Unintended Movement 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 2 2
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Peeled/Delaminated 1 1
Defective Component 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Structural Problem 1 1
Material Separation 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 288 288
No Consequences Or Impact To Patient 38 38
Insufficient Information 31 31
Foreign Body In Patient 4 4
No Patient Involvement 4 4
Bone Fracture(s) 2 2
No Known Impact Or Consequence To Patient 2 2
No Code Available 1 1
Perforation 1 1
Limb Fracture 1 1

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