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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 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6113 6113
Insufficient Information 66 66
Appropriate Term/Code Not Available 20 20
Device Operates Differently Than Expected 18 18
Off-Label Use 17 17
Migration or Expulsion of Device 16 16
Break 11 11
Patient-Device Incompatibility 8 8
Osseointegration Problem 8 8
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
Aspiration Issue 2 2
Failure to Osseointegrate 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Dislodged or Dislocated 2 2
Device Slipped 1 1
Fitting Problem 1 1
Extrusion 1 1
Entrapment of Device 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Problem with Sterilization 1 1
Collapse 1 1
Device Expiration Issue 1 1
Defective Device 1 1
Migration 1 1
Device Emits Odor 1 1
Difficult To Position 1 1
Device Contamination with Chemical or Other Material 1 1
Device Reprocessing Problem 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 3121 3121
Pain 2211 2211
Neuropathy 970 970
Numbness 714 714
Stenosis 628 628
Ambulation Difficulties 598 598
Ossification 590 590
Weakness 508 508
No Code Available 451 451
Tingling 439 439
Neck Pain 396 396
Loss of Range of Motion 300 300
Swelling 283 283
Nerve Damage 270 270
Muscle Spasm(s) 257 257
Headache 211 211
Sleep Dysfunction 205 205
Dysphagia/ Odynophagia 192 192
Burning Sensation 175 175
Inflammation 157 157
High Blood Pressure/ Hypertension 141 141
Depression 141 141
Cyst(s) 117 117
Chest Pain 114 114
Dyspnea 109 109
Nausea 107 107
Edema 102 102
Inadequate Pain Relief 97 97
Osteolysis 92 92
Unspecified Infection 89 89
Fatigue 82 82
Seroma 82 82
Discomfort 79 79
Incontinence 78 78
Dizziness 71 71
Arthritis 66 66
Hematoma 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
Hernia 39 39
Disc Impingement 38 38
Pneumonia 38 38

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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