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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 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 84 84
Off-Label Use 10 10
Osseointegration Problem 5 5
Insufficient Information 5 5
Appropriate Term/Code Not Available 3 3
Migration or Expulsion of Device 3 3
Failure to Osseointegrate 2 2
Microbial Contamination of Device 2 2
Device Contamination with Chemical or Other Material 1 1
Use of Device Problem 1 1
Nonstandard Device 1 1
Break 1 1
Entrapment of Device 1 1
Leak/Splash 1 1
Patient Device Interaction Problem 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 56 56
Neuropathy 13 13
Ambulation Difficulties 11 11
Inflammation 11 11
Failure of Implant 10 10
Unspecified Infection 8 8
Inadequate Osseointegration 7 7
Ossification 6 6
Bacterial Infection 6 6
Abscess 5 5
Fever 5 5
Nausea 5 5
Wound Dehiscence 5 5
Injury 5 5
Stenosis 4 4
Dysphagia/ Odynophagia 4 4
Swelling/ Edema 4 4
Insufficient Information 4 4
Unspecified Nervous System Problem 3 3
Cramp(s) /Muscle Spasm(s) 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Nerve Damage 3 3
Osteolysis 3 3
Seroma 3 3
Swelling 3 3
Burning Sensation 3 3
Sleep Dysfunction 3 3
Non-union Bone Fracture 3 3
Numbness 3 3
Neck Pain 3 3
Fungal Infection 2 2
Weakness 2 2
Paralysis 2 2
Diarrhea 2 2
Fistula 2 2
Rheumatoid Arthritis 2 2
Cellulitis 2 2
Cancer 2 2
Paresthesia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Intervertebral Disc Compression or Protrusion 1 1
Unspecified Tissue Injury 1 1
Cerebrospinal Fluid Leakage 1 1
Connective Tissue Disease 1 1
Cyst(s) 1 1
Dehydration 1 1
Abdominal Pain 1 1
Foreign Body Reaction 1 1
Bone Fracture(s) 1 1
Gastritis 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Dyspnea 1 1
Eye Injury 1 1
Fatigue 1 1
Purulent Discharge 1 1
Lupus 1 1
Muscle Spasm(s) 1 1
Muscle Weakness 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Scarring 1 1
Undesired Nerve Stimulation 1 1
Neurological Deficit/Dysfunction 1 1
Blood Loss 1 1
Disc Impingement 1 1
Fluid Discharge 1 1
No Known Impact Or Consequence To Patient 1 1
Test Result 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Spinal Cord Injury 1 1
Post Operative Wound Infection 1 1
Coma 1 1
Disability 1 1
Immunodeficiency 1 1
Chills 1 1
Dizziness 1 1
Blurred Vision 1 1
Impaired Healing 1 1
Arachnoiditis, Spinal 1 1
Reaction 1 1
Anxiety 1 1
Hypoesthesia 1 1
Depression 1 1

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