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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
2014 2 2
2017 1 1
2018 46 46
2019 54 54
2020 66 66
2021 173 173
2022 201 201
2023 386 386
2024 220 220

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 956 956
Dull, Blunt 136 136
Naturally Worn 38 38
Material Deformation 31 31
Break 20 20
Illegible Information 14 14
Device-Device Incompatibility 14 14
Material Twisted/Bent 10 10
Adverse Event Without Identified Device or Use Problem 5 5
Contamination /Decontamination Problem 5 5
No Apparent Adverse Event 3 3
Appropriate Term/Code Not Available 3 3
Scratched Material 3 3
Mechanical Problem 2 2
Material Integrity Problem 2 2
Loose or Intermittent Connection 2 2
Degraded 1 1
Use of Device Problem 1 1
Failure to Osseointegrate 1 1
Incorrect Measurement 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Improper or Incorrect Procedure or Method 1 1
Loss of Power 1 1
Corroded 1 1
Device Abrasion From Instrument Or Another Object 1 1
Insufficient Information 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 878 878
No Consequences Or Impact To Patient 148 148
Insufficient Information 122 122
No Code Available 12 12
Not Applicable 8 8
Limb Fracture 4 4
No Information 2 2
Bone Fracture(s) 1 1
No Known Impact Or Consequence To Patient 1 1
Nerve Damage 1 1
Missing Value Reason 1 1
Non-union Bone Fracture 1 1

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