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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)
2018 2019 2020 2021 2022 2023
2 6 4 3 4 0

MDR Year MDR Reports MDR Events
2018 178 178
2019 37 37
2020 31 31
2021 23 23
2022 8 8
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 252 252
Osseointegration Problem 4 4
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Microbial Contamination of Device 3 3
Migration or Expulsion of Device 3 3
Off-Label Use 3 3
Failure to Osseointegrate 2 2
Break 2 2
Leak/Splash 2 2
Device Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1
Migration 1 1
Device Reprocessing Problem 1 1
Entrapment of Device 1 1
Nonstandard Device 1 1
Fitting Problem 1 1
Problem with Sterilization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 130 130
Pain 91 91
Neuropathy 32 32
Ambulation Difficulties 31 31
Numbness 20 20
Ossification 12 12
Failure of Implant 12 12
Inflammation 11 11
Headache 10 10
Unspecified Infection 8 8
Swelling 8 8
Burning Sensation 7 7
Dysphagia/ Odynophagia 6 6
Weakness 6 6
Inadequate Osseointegration 6 6
Fever 5 5
Nausea 5 5
Wound Dehiscence 4 4
Muscle Weakness 4 4
Neurological Deficit/Dysfunction 4 4
Tingling 4 4
Stenosis 4 4
Seroma 4 4
Bacterial Infection 4 4
Cancer 4 4
Depression 4 4
Neck Pain 4 4
Sleep Dysfunction 4 4
Disability 3 3
No Code Available 3 3
Insufficient Information 3 3
Abdominal Pain 3 3
Abscess 3 3
Cyst(s) 3 3
Hematoma 3 3
Incontinence 3 3
Bone Fracture(s) 2 2
Rheumatoid Arthritis 2 2
Atrial Fibrillation 2 2
Diarrhea 2 2
Cellulitis 2 2
Dyspnea 2 2
Edema 2 2
Respiratory Distress 2 2
Scarring 2 2
Anxiety 2 2
Paralysis 2 2
Muscle Spasm(s) 2 2
Nerve Damage 2 2
Swelling/ Edema 2 2
Blood Loss 2 2
Osteolysis 2 2
Inadequate Pain Relief 2 2
Non-union Bone Fracture 2 2
Reaction 2 2
Fungal Infection 2 2
Claudication 1 1
Hematuria 1 1
Prolapse 1 1
Coma 1 1
Arachnoiditis, Spinal 1 1
Unspecified Nervous System Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Unspecified Tissue Injury 1 1
Disc Impingement 1 1
Fluid Discharge 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
Test Result 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 1 1
Undesired Nerve Stimulation 1 1
Infiltration into Tissue 1 1
Irritation 1 1
Lupus 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Rash 1 1
Overdose 1 1
Hypoesthesia 1 1
Chills 1 1
Dizziness 1 1
Immunodeficiency 1 1
Increased Sensitivity 1 1
Sepsis 1 1
Skin Irritation 1 1
Synovitis 1 1
Blurred Vision 1 1
Embolus 1 1
Emotional Changes 1 1
Erythema 1 1
Eye Injury 1 1
Fall 1 1
Fatigue 1 1
Cerebrospinal Fluid Leakage 1 1
Chest Pain 1 1
Connective Tissue Disease 1 1
Adhesion(s) 1 1
Anemia 1 1
Purulent Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Sofamor Danek USA Inc II Nov-09-2018
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