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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bone mill
Regulation Description Orthopedic manual surgical instrument.
Product CodeLYS
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2021 173 173
2022 201 201
2023 386 387
2024 305 305
2025 26 26
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1018 1019
Naturally Worn 45 45
Material Deformation 30 30
Break 27 27
Illegible Information 14 14
Device-Device Incompatibility 9 9
Detachment of Device or Device Component 8 8
Scratched Material 7 7
Material Twisted/Bent 6 6
Contamination /Decontamination Problem 5 5
Adverse Event Without Identified Device or Use Problem 3 3
No Apparent Adverse Event 3 3
Improper or Incorrect Procedure or Method 3 3
Mechanical Problem 2 2
Material Integrity Problem 2 2
Device Remains Activated 1 1
Degraded 1 1
Failure to Osseointegrate 1 1
Incorrect Measurement 1 1
Corroded 1 1
Loss of Power 1 1
Device Displays Incorrect Message 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 966 967
Insufficient Information 138 138
Limb Fracture 6 6
Bone Fracture(s) 1 1
Non-union Bone Fracture 1 1

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