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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Product CodeNEK
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
6 4 3 4 4 0

MDR Year MDR Reports MDR Events
2019 37 37
2020 31 31
2021 23 23
2022 8 8
2023 14 14
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 90 90
Off-Label Use 15 15
Osseointegration Problem 8 8
Insufficient Information 5 5
Migration or Expulsion of Device 3 3
Appropriate Term/Code Not Available 3 3
Failure to Osseointegrate 2 2
Microbial Contamination of Device 2 2
Entrapment of Device 1 1
Break 1 1
Leak/Splash 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Migration 1 1
Device Contamination with Chemical or Other Material 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 59 59
Neuropathy 13 13
Ambulation Difficulties 12 12
Inflammation 11 11
Failure of Implant 10 10
Unspecified Infection 9 9
Inadequate Osseointegration 9 9
No Clinical Signs, Symptoms or Conditions 7 7
Bacterial Infection 7 7
Ossification 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Wound Dehiscence 5 5
Nausea 5 5
Abscess 5 5
Injury 5 5
Fever 5 5
Stenosis 5 5
Dysphagia/ Odynophagia 5 5
Insufficient Information 4 4
Seroma 4 4
Swelling/ Edema 4 4
Unspecified Nervous System Problem 4 4
Sleep Dysfunction 3 3
Numbness 3 3
Osteolysis 3 3
Swelling 3 3
Nerve Damage 3 3
Neck Pain 3 3
Burning Sensation 3 3
Non-union Bone Fracture 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Diarrhea 2 2
Weakness 2 2
Paralysis 2 2
Cellulitis 2 2
Fungal Infection 2 2
Cancer 2 2
Fistula 2 2
Rheumatoid Arthritis 2 2
Undesired Nerve Stimulation 1 1
Fluid Discharge 1 1
Reaction 1 1
Pneumonia 1 1
Anxiety 1 1
Unspecified Tissue Injury 1 1
Cerebrospinal Fluid Leakage 1 1
Hypoxia 1 1
Blurred Vision 1 1
Immunodeficiency 1 1
Eye Injury 1 1

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