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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, fixation device, spinal
Product CodeJDN
Regulation Number 888.3060
Device Class 2

MDR Year MDR Reports MDR Events
2017 6 6
2018 2 2
2019 6 6
2020 6 6
2021 2 2
2022 16 16
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 9 9
Break 8 8
Material Separation 8 8
Adverse Event Without Identified Device or Use Problem 5 5
Positioning Failure 2 2
Fracture 2 2
Mechanical Problem 2 2
Migration or Expulsion of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Patient-Device Incompatibility 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
Failure of Implant 6 6
Pain 4 4
Implant Pain 4 4
Patient Problem/Medical Problem 3 3
No Code Available 3 3
Unspecified Infection 3 3
Laceration(s) 1 1
Abscess 1 1
Fall 1 1
Tissue Damage 1 1
Non-union Bone Fracture 1 1
Impaired Healing 1 1
No Patient Involvement 1 1
Insufficient Information 1 1

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