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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
Appropriate Term/Code Not Available 4 4
Device Operates Differently Than Expected 4 4
Patient-Device Incompatibility 3 3
Fracture 3 3
Device Dislodged or Dislocated 3 3
Migration or Expulsion of Device 2 2
Material Integrity Problem 2 2
Positioning Failure 2 2
Material Deformation 1 1
Detachment Of Device Component 1 1
Sticking 1 1
Crack 1 1
Device Slipped 1 1
Detachment of Device or Device Component 1 1
Positioning Problem 1 1
Malposition of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Compatibility Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Open or Close 1 1

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

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