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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
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 20 20
Loss of Osseointegration 8 8
Osseointegration Problem 2 2
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 22 22
Pain 16 16
Unspecified Infection 12 12
Inadequate Osseointegration 8 8
Tissue Damage 5 5
Discomfort 5 5
Pulmonary Embolism 4 4
Cardiac Arrest 3 3
Necrosis 3 3
Limited Mobility Of The Implanted Joint 3 3
Hypersensitivity/Allergic reaction 3 3
Injury 2 2
Weakness 2 2
Inflammation 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
No Consequences Or Impact To Patient 1 1
Anxiety 1 1
Deformity/ Disfigurement 1 1
Osteolysis 1 1
Ambulation Difficulties 1 1

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