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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
3 4 4 6 6 1 4 3 5 2 6 4 3 4 4 0

MDR Year MDR Reports MDR Events
2014 1926 1926
2015 1732 1732
2016 1528 1528
2017 799 799
2018 178 178
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 6107 6107
Insufficient Information 66 66
Appropriate Term/Code Not Available 20 20
Device Operates Differently Than Expected 18 18
Migration or Expulsion of Device 16 16
Off-Label Use 12 12
Break 11 11
Patient-Device Incompatibility 8 8
Osseointegration Problem 5 5
Malposition of Device 4 4
Microbial Contamination of Device 3 3
Nonstandard Device 3 3
Improper or Incorrect Procedure or Method 3 3
Leak/Splash 2 2
Failure to Osseointegrate 2 2
Aspiration Issue 2 2
Device Dislodged or Dislocated 2 2
Therapeutic or Diagnostic Output Failure 2 2
Patient Device Interaction Problem 1 1
Migration 1 1
Extrusion 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Structural Problem 1 1
Fitting Problem 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Device Slipped 1 1
Problem with Sterilization 1 1
Use of Device Problem 1 1
Device Emits Odor 1 1
Difficult To Position 1 1
Device Reprocessing Problem 1 1
Collapse 1 1
Entrapment of Device 1 1
Device Expiration Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 3121 3121
Pain 2208 2208
Neuropathy 969 969
Numbness 713 713
Stenosis 627 627
Ambulation Difficulties 596 596
Ossification 588 588
Weakness 508 508
No Code Available 451 451
Tingling 439 439
Neck Pain 395 395
Loss of Range of Motion 300 300
Swelling 283 283
Nerve Damage 270 270
Muscle Spasm(s) 257 257
Headache 211 211
Sleep Dysfunction 204 204
Dysphagia/ Odynophagia 191 191
Burning Sensation 174 174
Inflammation 157 157
High Blood Pressure/ Hypertension 141 141
Depression 140 140
Cyst(s) 116 116
Chest Pain 114 114
Dyspnea 108 108
Nausea 106 106
Edema 102 102
Inadequate Pain Relief 97 97
Osteolysis 92 92
Unspecified Infection 88 88
Fatigue 81 81
Seroma 81 81
Discomfort 79 79
Incontinence 77 77
Dizziness 71 71
Hematoma 65 65
Arthritis 65 65
Respiratory Distress 62 62
Vomiting 61 61
Neck Stiffness 58 58
Cramp(s) 57 57
Post Operative Wound Infection 50 50
Fever 48 48
Urinary Tract Infection 47 47
Anxiety 46 46
Muscle Weakness 43 43
Nerve Proximity Nos (Not Otherwise Specified) 40 40
Disc Impingement 38 38
Hernia 38 38
Pneumonia 38 38
Scarring 35 35
Abdominal Pain 33 33
Chronic Obstructive Pulmonary Disease (COPD) 33 33
Disability 33 33
Dysphasia 32 32
Bone Fracture(s) 32 32
Paralysis 32 32
Thyroid Problems 29 29
Palpitations 29 29
Rash 27 27
Diarrhea 27 27
Wound Dehiscence 27 27
Bronchitis 26 26
Sore Throat 26 26
No Known Impact Or Consequence To Patient 25 25
Anemia 24 24
Neurological Deficit/Dysfunction 23 23
Arachnoiditis, Spinal 23 23
Weight Changes 22 22
Urinary Retention 20 20
Scar Tissue 20 20
Fall 20 20
No Information 19 19
Bacterial Infection 18 18
Failure of Implant 18 18
Arthralgia 18 18
Joint Swelling 17 17
Chills 17 17
Osteopenia/ Osteoporosis 17 17
Sweating 17 17
Respiratory Tract Infection 17 17
Patient Problem/Medical Problem 17 17
Dysuria 17 17
Shaking/Tremors 15 15
Malaise 15 15
Tachycardia 15 15
Asthma 15 15
Sinus Perforation 14 14
Myalgia 14 14
Cancer 14 14
Ulcer 13 13
Urinary Frequency 13 13
Syncope 13 13
Contusion 13 13
Death 13 13
Hearing Loss 13 13
Calcium Deposits/Calcification 12 12
Apnea 12 12
Abscess 12 12
Distress 12 12

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Sofamor Danek USA Inc II Nov-09-2018
2 Medtronic Sofamor Danek USA Inc II Jun-25-2013
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