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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mallet
Regulation Description Manual surgical instrument for general use.
Product CodeHXL
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2021 8 8
2022 1 1
2023 4 4
2024 4 4
2025 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Material Deformation 2 2
Material Fragmentation 2 2
Loose or Intermittent Connection 1 1
Unraveled Material 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Detachment of Device or Device Component 1 1
Insufficient Information 1 1
Fluid/Blood Leak 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17 17
Insufficient Information 2 2
Fatigue 1 1
Confusion/ Disorientation 1 1
Foreign Body In Patient 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Depression 1 1
Pain 1 1
Blurred Vision 1 1
Convulsion/Seizure 1 1
Headache 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Implant Resource Inc II Oct-16-2021
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