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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device screw, fixation, bone, non-spinal, metallic
Product CodeNDJ
Regulation Number 888.3040
Device Class 2

MDR Year MDR Reports MDR Events
2018 8 8
2019 22 22
2020 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 26 26
Loss of Osseointegration 10 10
Osseointegration Problem 3 3
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 27 27
Pain 21 21
Unspecified Infection 18 18
Inadequate Osseointegration 10 10
Discomfort 9 9
Tissue Damage 6 6
Limited Mobility Of The Implanted Joint 6 6
Pulmonary Embolism 4 4
Erosion 3 3
Cardiac Arrest 3 3
Inflammation 3 3
Necrosis 3 3
Hypersensitivity/Allergic reaction 3 3
Swelling 3 3
Weakness 2 2
Injury 2 2
Loss of Range of Motion 2 2
Infarction, Cerebral 2 2
Foreign Body Reaction 2 2
Hematoma 1 1
Adhesion(s) 1 1
Cyst(s) 1 1
Edema 1 1
Fatigue 1 1
Scar Tissue 1 1
Sepsis 1 1
Nerve Damage 1 1
Deformity/ Disfigurement 1 1
Osteolysis 1 1
Ambulation Difficulties 1 1
No Consequences Or Impact To Patient 1 1
Anxiety 1 1

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