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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

MDR Year MDR Reports MDR Events
2018 134 134
2019 188 188
2020 115 115
2021 274 274
2022 215 215
2023 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 391 391
Break 234 234
Fracture 63 63
Device-Device Incompatibility 54 54
Migration 49 49
No Apparent Adverse Event 40 40
Device Slipped 40 40
Appropriate Term/Code Not Available 38 38
Material Integrity Problem 36 36
Material Separation 29 29
Detachment of Device or Device Component 24 24
Patient Device Interaction Problem 21 21
Insufficient Information 20 20
Material Fragmentation 17 17
Entrapment of Device 16 16
Compatibility Problem 15 15
Material Twisted/Bent 14 14
Loosening of Implant Not Related to Bone-Ingrowth 12 12
Material Deformation 11 11
Mechanical Problem 9 9
Migration or Expulsion of Device 8 8
Failure To Adhere Or Bond 8 8
Device Operational Issue 8 8
Unintended Movement 8 8
Mechanical Jam 6 6
Material Split, Cut or Torn 6 6
Device Dislodged or Dislocated 6 6
Improper or Incorrect Procedure or Method 5 5
Fitting Problem 4 4
Structural Problem 4 4
Patient-Device Incompatibility 4 4
Device Operates Differently Than Expected 4 4
Component or Accessory Incompatibility 3 3
Use of Device Problem 3 3
Malposition of Device 3 3
Loose or Intermittent Connection 3 3
Positioning Problem 3 3
Physical Resistance/Sticking 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Insert 2 2
Loss of or Failure to Bond 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Inadequacy of Device Shape and/or Size 2 2
Separation Failure 2 2
Defective Device 2 2
Solder Joint Fracture 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Difficult to Advance 1 1
Device Damaged by Another Device 1 1
Inadequate or Insufficient Training 1 1
Misassembled 1 1
Crack 1 1
Disconnection 1 1
Measurement System Incompatibility 1 1
Output Problem 1 1
Packaging Problem 1 1
Misassembly by Users 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 172 172
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 112 112
Pain 105 105
No Code Available 103 103
Failure of Implant 84 84
No Known Impact Or Consequence To Patient 77 77
Non-union Bone Fracture 63 63
Nerve Damage 59 59
Post Operative Wound Infection 58 58
Insufficient Information 55 55
Unspecified Tissue Injury 48 48
No Information 43 43
No Consequences Or Impact To Patient 43 43
Unspecified Infection 37 37
Osteolysis 37 37
Bone Fracture(s) 30 30
Perforation of Vessels 27 27
Intervertebral Disc Compression or Protrusion 24 24
Hematoma 23 23
Physical Asymmetry 20 20
Foreign Body In Patient 18 18
Not Applicable 15 15
Cerebrospinal Fluid Leakage 15 15
Vertebral Fracture 15 15
Injury 14 14
Device Embedded In Tissue or Plaque 12 12
Discomfort 11 11
Spinal Cord Injury 11 11
Limited Mobility Of The Implanted Joint 10 10
Neuralgia 10 10
Spinal Column Injury 10 10
Decreased Sensitivity 9 9
Impaired Healing 9 9
Malunion of Bone 9 9
Joint Laxity 8 8
Neck Pain 8 8
Joint Disorder 8 8
Sudden Cardiac Death 8 8
Necrosis 7 7
Hemorrhage/Bleeding 5 5
Implant Pain 4 4
Neurological Deficit/Dysfunction 3 3
Ambulation Difficulties 3 3
Unspecified Nervous System Problem 3 3
Patient Problem/Medical Problem 2 2
Thromboembolism 2 2
Numbness 2 2
Complaint, Ill-Defined 2 2
Muscular Rigidity 2 2
Wound Dehiscence 2 2
Fall 2 2
Fatigue 2 2
Seroma 2 2
Synovitis 2 2
Stenosis 2 2
Anxiety 1 1
Excessive Tear Production 1 1
Thrombosis 1 1
Urinary Tract Infection 1 1
Visual Impairment 1 1
Weakness 1 1
Swelling 1 1
Paralysis 1 1
Paresis 1 1
Rash 1 1
Scarring 1 1
Sepsis 1 1
Fistula 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Cyst(s) 1 1
Death 1 1
Erythema 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoesthesia 1 1
Respiratory Tract Infection 1 1
Cognitive Changes 1 1
No Patient Involvement 1 1
Vascular Dissection 1 1
Embolism/Embolus 1 1
Thrombosis/Thrombus 1 1
Balance Problems 1 1
Swelling/ Edema 1 1
Unspecified Musculoskeletal problem 1 1
Skin Inflammation/ Irritation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CTL Medical Corporation II Mar-20-2019
2 Medicrea International II Aug-24-2023
3 New Era Orthopaedics, LLc II Aug-03-2018
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