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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)
2020 2021 2022 2023 2024 2025
4 3 4 4 1 1

MDR Year MDR Reports MDR Events
2020 31 31
2021 23 23
2022 8 8
2023 14 14
2024 36 36
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 67 67
Off-Label Use 21 21
Osseointegration Problem 14 14
Insufficient Information 5 5
Appropriate Term/Code Not Available 3 3
Microbial Contamination of Device 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Failure to Osseointegrate 2 2
Break 1 1
Entrapment of Device 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Migration 1 1
Nonstandard Device 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 44 44
No Clinical Signs, Symptoms or Conditions 13 13
Inadequate Osseointegration 11 11
Unspecified Infection 10 10
Neuropathy 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Bacterial Infection 7 7
Inflammation 7 7
Wound Dehiscence 6 6
Abscess 5 5
Muscle Weakness 5 5
Unspecified Nervous System Problem 5 5
Ambulation Difficulties 4 4
Stenosis 4 4
Insufficient Information 4 4
Non-union Bone Fracture 4 4
Ossification 4 4
Swelling/ Edema 4 4
Seroma 4 4
Fever 4 4
Sleep Dysfunction 3 3
Numbness 3 3
Swelling 3 3
Cancer 3 3
Nerve Damage 3 3
Muscular Rigidity 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Neck Pain 3 3
Spinal Column Injury 3 3
Fluid Discharge 2 2
Dysphagia/ Odynophagia 2 2
Osteolysis 2 2
Diarrhea 2 2
Burning Sensation 2 2
Cellulitis 2 2
Bone Fracture(s) 2 2
Fungal Infection 2 2
Nausea 2 2
Failure of Implant 2 2
Rheumatoid Arthritis 2 2
Fistula 2 2
Hypoxia 1 1
Blurred Vision 1 1
Immunodeficiency 1 1
Cerebrospinal Fluid Leakage 1 1
Ulcer 1 1
Unspecified Tissue Injury 1 1
Disc Impingement 1 1
Intervertebral Disc Compression or Protrusion 1 1
Hypoesthesia 1 1

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