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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)
2021 2022 2023 2024 2025 2026
3 4 4 1 1 3

MDR Year MDR Reports MDR Events
2021 23 23
2022 8 8
2023 14 14
2024 36 36
2025 52 52
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 60 60
Off-Label Use 53 53
Osseointegration Problem 17 17
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
Material Split, Cut or Torn 1 1
Break 1 1
Entrapment of Device 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 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 38 38
No Clinical Signs, Symptoms or Conditions 35 35
Swelling/ Edema 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Seroma 12 12
Unspecified Infection 11 11
Neuropathy 10 10
Inadequate Osseointegration 9 9
Stenosis 9 9
Ossification 9 9
Inflammation 8 8
Bacterial Infection 7 7
Non-union Bone Fracture 6 6
Discomfort 6 6
Erythema 6 6
Unspecified Nervous System Problem 6 6
Wound Dehiscence 5 5
Abscess 5 5
Muscle Weakness 5 5
Insufficient Information 5 5
Fever 4 4
Spinal Cord Injury 3 3
Dysphagia/ Odynophagia 3 3
Bone Fracture(s) 3 3
Muscular Rigidity 3 3
Osteolysis 3 3
Nerve Damage 3 3
Spinal Column Injury 3 3
Urinary Tract Infection 2 2
Pulmonary Embolism 2 2
Ambulation Difficulties 2 2
Cancer 2 2
Cerebrospinal Fluid Leakage 2 2
Fluid Discharge 2 2
Diarrhea 2 2
Post Traumatic Wound Infection 2 2
Post Operative Wound Infection 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Nausea 2 2
Necrosis 2 2
Sepsis 2 2
Fungal Infection 2 2
Sleep Dysfunction 1 1
Impaired Healing 1 1
Fistula 1 1
Device Embedded In Tissue or Plaque 1 1
Encephalopathy 1 1
Vertebral Fracture 1 1
Swollen Lymph Nodes/Glands 1 1
Apnea 1 1

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