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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, spinal pedicle fixation
Product CodeMNI
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
MIKRON MAKINA SANAYI TICARET CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 246 246
2018 134 134
2019 188 188
2020 115 115
2021 274 274
2022 165 165

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 389 389
Break 258 258
Fracture 85 85
Migration or Expulsion of Device 53 53
Material Integrity Problem 45 45
Migration 40 40
Appropriate Term/Code Not Available 38 38
Device Slipped 33 33
Loose or Intermittent Connection 32 32
Mechanical Problem 31 31
Material Separation 31 31
No Apparent Adverse Event 27 27
Device-Device Incompatibility 23 23
Detachment of Device or Device Component 23 23
Unintended Movement 22 22
Insufficient Information 21 21
Device Dislodged or Dislocated 19 19
Material Fragmentation 19 19
Material Deformation 18 18
Patient Device Interaction Problem 17 17
Material Twisted/Bent 16 16
Device Operates Differently Than Expected 15 15
Detachment Of Device Component 15 15
Entrapment of Device 14 14
Compatibility Problem 12 12
Loosening of Implant Not Related to Bone-Ingrowth 12 12
Device Operational Issue 9 9
Failure To Adhere Or Bond 9 9
Disassembly 8 8
Noise, Audible 7 7
Mechanical Jam 7 7
Material Split, Cut or Torn 5 5
Device Damaged by Another Device 5 5
Improper or Incorrect Procedure or Method 5 5
Fitting Problem 5 5
Use of Device Problem 5 5
Malposition of Device 5 5
Patient-Device Incompatibility 4 4
Structural Problem 4 4
Bent 4 4
Defective Device 4 4
Positioning Problem 4 4
Component or Accessory Incompatibility 3 3
Connection Problem 3 3
Difficult to Insert 3 3
Difficult to Remove 3 3
Difficult To Position 2 2
Product Quality Problem 2 2
Disconnection 2 2
Loss of or Failure to Bond 2 2
Crack 2 2
Device Damaged Prior to Use 2 2
Tear, Rip or Hole in Device Packaging 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Torn Material 2 2
Misassembly by Users 1 1
Output Problem 1 1
Packaging Problem 1 1
Physical Resistance/Sticking 1 1
Human Factors Issue 1 1
Measurement System Incompatibility 1 1
Material Torqued 1 1
Component Missing 1 1
Solder Joint Fracture 1 1
Inadequacy of Device Shape and/or Size 1 1
Inadequate or Insufficient Training 1 1
Failure to Align 1 1
Separation Failure 1 1
Metal Shedding Debris 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 167 167
No Code Available 136 136
Failure of Implant 123 123
Pain 120 120
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 109 109
No Clinical Signs, Symptoms or Conditions 98 98
No Information 71 71
No Consequences Or Impact To Patient 62 62
Nerve Damage 59 59
Non-union Bone Fracture 57 57
Post Operative Wound Infection 53 53
Injury 49 49
Unspecified Tissue Injury 45 45
Bone Fracture(s) 32 32
Osteolysis 28 28
Insufficient Information 28 28
Perforation of Vessels 27 27
Unspecified Infection 24 24
Impaired Healing 24 24
Intervertebral Disc Compression or Protrusion 24 24
Foreign Body In Patient 23 23
Hematoma 23 23
Device Embedded In Tissue or Plaque 19 19
Physical Asymmetry 19 19
Vertebral Fracture 15 15
Not Applicable 15 15
Cerebrospinal Fluid Leakage 14 14
Spinal Column Injury 13 13
Discomfort 12 12
Neuralgia 10 10
Limited Mobility Of The Implanted Joint 10 10
Spinal Cord Injury 10 10
Decreased Sensitivity 9 9
Neck Pain 8 8
Joint Disorder 8 8
Sedation 8 8
Sudden Cardiac Death 8 8
Joint Laxity 8 8
Malunion of Bone 8 8
Necrosis 7 7
Patient Problem/Medical Problem 6 6
Ambulation Difficulties 4 4
Hemorrhage/Bleeding 4 4
Neurological Deficit/Dysfunction 4 4
Implant Pain 4 4
Fall 3 3
Weakness 3 3
Complaint, Ill-Defined 2 2
Numbness 2 2
No Patient Involvement 2 2
Thromboembolism 2 2
Unspecified Nervous System Problem 2 2
Pulmonary Embolism 2 2
Hypersensitivity/Allergic reaction 2 2
Muscular Rigidity 2 2
Synovitis 2 2
Thrombosis 1 1
Urinary Tract Infection 1 1
Visual Impairment 1 1
Excessive Tear Production 1 1
Stenosis 1 1
Pressure Sores 1 1
Anxiety 1 1
Swelling 1 1
Paralysis 1 1
Paresis 1 1
Scarring 1 1
Sepsis 1 1
Seroma 1 1
Wound Dehiscence 1 1
Anemia 1 1
Arthritis 1 1
Fatigue 1 1
Fistula 1 1
Cyst(s) 1 1
Death 1 1
Erythema 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Vascular Dissection 1 1
Respiratory Tract Infection 1 1
Cognitive Changes 1 1
Hypoesthesia 1 1
Unspecified Musculoskeletal problem 1 1
Skin Inflammation/ Irritation 1 1
Balance Problems 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CTL Medical Corporation II Mar-20-2019
2 New Era Orthopaedics, LLc II Aug-03-2018
3 Valorem Surgical LLC II Aug-10-2017
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