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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
Regulation Description Thoracolumbosacral pedicle screw system.
Product CodeMNI
Regulation Number 888.3070
Device Class 2

MDR Year MDR Reports MDR Events
2020 115 115
2021 270 270
2022 215 215
2023 123 123
2024 114 114
2025 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 369 369
Break 193 193
Device-Device Incompatibility 51 51
Migration 40 40
Fracture 36 36
Device Slipped 35 35
Material Integrity Problem 28 28
Appropriate Term/Code Not Available 27 27
Patient Device Interaction Problem 24 24
Compatibility Problem 22 22
Insufficient Information 21 21
No Apparent Adverse Event 20 20
Entrapment of Device 16 16
Detachment of Device or Device Component 14 14
Material Twisted/Bent 11 11
Mechanical Problem 8 8
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Material Fragmentation 5 5
Patient-Device Incompatibility 4 4
Material Deformation 4 4
Material Split, Cut or Torn 3 3
Positioning Problem 3 3
Loose or Intermittent Connection 2 2
Device Dislodged or Dislocated 2 2
Material Separation 2 2
Difficult to Remove 2 2
Defective Device 2 2
Unintended Movement 2 2
Component or Accessory Incompatibility 2 2
Fitting Problem 2 2
Failure to Osseointegrate 1 1
Device Damaged by Another Device 1 1
Difficult to Advance 1 1
Solder Joint Fracture 1 1
Calibration Problem 1 1
Separation Failure 1 1
Crack 1 1
Physical Resistance/Sticking 1 1
Inadequacy of Device Shape and/or Size 1 1
Malposition of Device 1 1
Migration or Expulsion of Device 1 1
Device Appears to Trigger Rejection 1 1
Improper or Incorrect Procedure or Method 1 1
Deformation Due to Compressive Stress 1 1
Mechanical Jam 1 1
Loss of or Failure to Bond 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 215 215
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 110 110
Insufficient Information 108 108
Non-union Bone Fracture 74 74
Pain 72 72
Post Operative Wound Infection 70 70
Nerve Damage 60 60
Failure of Implant 55 55
Unspecified Tissue Injury 53 53
Osteolysis 45 45
Unspecified Infection 43 43
Bone Fracture(s) 34 34
Joint Laxity 31 31
Cerebrospinal Fluid Leakage 29 29
Perforation of Vessels 29 29
Hematoma 29 29
No Consequences Or Impact To Patient 27 27
No Code Available 26 26
No Known Impact Or Consequence To Patient 24 24
Intervertebral Disc Compression or Protrusion 24 24
Physical Asymmetry 22 22
Decreased Sensitivity 20 20
Vertebral Fracture 17 17
Foreign Body In Patient 16 16
Spinal Cord Injury 15 15
Neuralgia 10 10
Malunion of Bone 9 9
Implant Pain 7 7
Neck Pain 7 7
Impaired Healing 7 7
Thromboembolism 6 6
Loss of Range of Motion 6 6
Necrosis 5 5
Unspecified Nervous System Problem 5 5
Injury 5 5
Thrombosis/Thrombus 5 5
Hemorrhage/Bleeding 5 5
Discomfort 5 5
Device Embedded In Tissue or Plaque 3 3
Ambulation Difficulties 3 3
Burning Sensation 3 3
Numbness 3 3
Hypersensitivity/Allergic reaction 3 3
Synovitis 2 2
Embolism/Embolus 2 2
Seroma 2 2
Deformity/ Disfigurement 2 2
Muscular Rigidity 2 2
Fatigue 2 2
Unspecified Kidney or Urinary Problem 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Medicrea International II Aug-24-2023
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