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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
2019 188 188
2020 115 115
2021 274 274
2022 215 215
2023 123 123
2024 104 104

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 427 427
Break 205 205
Migration 52 52
Device-Device Incompatibility 51 51
Fracture 49 49
No Apparent Adverse Event 43 43
Device Slipped 38 38
Appropriate Term/Code Not Available 34 34
Material Integrity Problem 34 34
Insufficient Information 29 29
Patient Device Interaction Problem 29 29
Detachment of Device or Device Component 21 21
Compatibility Problem 17 17
Entrapment of Device 16 16
Material Separation 14 14
Material Twisted/Bent 11 11
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Material Deformation 10 10
Mechanical Problem 8 8
Mechanical Jam 6 6
Material Split, Cut or Torn 6 6
Migration or Expulsion of Device 6 6
Device Dislodged or Dislocated 5 5
Material Fragmentation 5 5
Unintended Movement 5 5
Structural Problem 4 4
Patient-Device Incompatibility 4 4
Improper or Incorrect Procedure or Method 4 4
Positioning Problem 3 3
Component or Accessory Incompatibility 3 3
Fitting Problem 3 3
Difficult to Remove 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Defective Device 2 2
Use of Device Problem 2 2
Product Quality Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Physical Resistance/Sticking 2 2
Loose or Intermittent Connection 2 2
Difficult to Advance 1 1
Device Damaged by Another Device 1 1
Separation Failure 1 1
Misassembled 1 1
Solder Joint Fracture 1 1
Calibration Problem 1 1
Packaging Problem 1 1
Misassembly by Users 1 1
Crack 1 1
Output Problem 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 199 199
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 112 112
Insufficient Information 101 101
Pain 95 95
Nerve Damage 76 76
Non-union Bone Fracture 75 75
Failure of Implant 74 74
No Code Available 74 74
Post Operative Wound Infection 71 71
No Known Impact Or Consequence To Patient 56 56
Unspecified Infection 53 53
Unspecified Tissue Injury 53 53
Osteolysis 50 50
Bone Fracture(s) 40 40
No Consequences Or Impact To Patient 34 34
Hematoma 33 33
Joint Laxity 31 31
Perforation of Vessels 29 29
Cerebrospinal Fluid Leakage 29 29
Intervertebral Disc Compression or Protrusion 24 24
Physical Asymmetry 22 22
Decreased Sensitivity 20 20
Vertebral Fracture 17 17
Foreign Body In Patient 17 17
No Information 16 16
Spinal Cord Injury 15 15
Impaired Healing 13 13
Limited Mobility Of The Implanted Joint 10 10
Neuralgia 10 10
Injury 9 9
Malunion of Bone 9 9
Joint Disorder 8 8
Neck Pain 8 8
Necrosis 7 7
Implant Pain 7 7
Discomfort 7 7
Thromboembolism 6 6
Loss of Range of Motion 6 6
Device Embedded In Tissue or Plaque 6 6
Hemorrhage/Bleeding 5 5
Not Applicable 5 5
Unspecified Nervous System Problem 5 5
Thrombosis/Thrombus 5 5
Spinal Column Injury 4 4
Neurological Deficit/Dysfunction 3 3
Seroma 3 3
Ambulation Difficulties 3 3
Deformity/ Disfigurement 2 2
Stenosis 2 2
Pulmonary Embolism 2 2

Recalls
Manufacturer Recall Class Date Posted
1 CTL Medical Corporation II Mar-20-2019
2 Medicrea International II Aug-24-2023
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