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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bone mill
Product CodeLYS
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 54 54
2020 66 66
2021 173 173
2022 201 201
2023 386 386
2024 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 812 812
Dull, Blunt 94 94
Material Deformation 31 31
Naturally Worn 31 31
Break 20 20
Device-Device Incompatibility 14 14
Illegible Information 14 14
Material Twisted/Bent 10 10
Adverse Event Without Identified Device or Use Problem 5 5
Contamination /Decontamination Problem 5 5
Scratched Material 3 3
No Apparent Adverse Event 3 3
Appropriate Term/Code Not Available 3 3
Material Integrity Problem 2 2
Mechanical Problem 2 2
Loose or Intermittent Connection 2 2
Incorrect Measurement 1 1
Corroded 1 1
Degraded 1 1
Failure to Osseointegrate 1 1
Improper or Incorrect Procedure or Method 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 783 783
No Consequences Or Impact To Patient 104 104
Insufficient Information 60 60
No Code Available 11 11
Not Applicable 6 6
Limb Fracture 4 4
Bone Fracture(s) 1 1
Non-union Bone Fracture 1 1
No Known Impact Or Consequence To Patient 1 1

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