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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
2014 17 17
2015 23 23
2016 2 2
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
Break 15 15
Adverse Event Without Identified Device or Use Problem 15 15
Insufficient Information 11 11
Material Split, Cut or Torn 9 9
Material Separation 8 8
Mechanical Problem 4 4
Device Operates Differently Than Expected 4 4
Appropriate Term/Code Not Available 4 4
Device Dislodged or Dislocated 3 3
Patient-Device Incompatibility 3 3
Fracture 3 3
Positioning Failure 2 2
Migration or Expulsion of Device 2 2
Material Integrity Problem 2 2
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Detachment of Device or Device Component 1 1
Compatibility Problem 1 1
Material Deformation 1 1
Difficult to Open or Close 1 1
Detachment Of Device Component 1 1
Crack 1 1
Device Slipped 1 1
Sticking 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18 18
Unspecified Infection 12 12
No Code Available 12 12
Failure of Implant 10 10
Pain 9 9
No Known Impact Or Consequence To Patient 8 8
Impaired Healing 6 6
Neurological Deficit/Dysfunction 5 5
Hematoma 5 5
Bone Fracture(s) 4 4
Bacterial Infection 4 4
Seroma 4 4
Implant Pain 4 4
Joint Disorder 4 4
Patient Problem/Medical Problem 3 3
Injury 3 3
Post Operative Wound Infection 2 2
Fluid Discharge 2 2
Spinal Column Injury 2 2
Dysphagia/ Odynophagia 2 2
Fall 1 1
Cerebrospinal Fluid Leakage 1 1
Abscess 1 1
High Blood Pressure/ Hypertension 1 1
Swelling 1 1
Tissue Damage 1 1
Tingling 1 1
No Consequences Or Impact To Patient 1 1
Complaint, Ill-Defined 1 1
Laceration(s) 1 1
Nervous System Injury 1 1
Insufficient Information 1 1
No Information 1 1
No Patient Involvement 1 1
Alteration In Body Temperature 1 1
Spinal Cord Injury 1 1
Neck Pain 1 1
Non-union Bone Fracture 1 1
Paralysis 1 1

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