Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 414 414
Break 186 186
Device-Device Incompatibility 51 51
Migration 46 46
No Apparent Adverse Event 43 43
Fracture 43 43
Device Slipped 36 36
Material Integrity Problem 34 34
Appropriate Term/Code Not Available 34 34
Patient Device Interaction Problem 29 29
Insufficient Information 27 27
Detachment of Device or Device Component 20 20
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
Migration or Expulsion of Device 6 6
Material Split, Cut or Torn 6 6
Mechanical Jam 6 6
Unintended Movement 5 5
Material Fragmentation 5 5
Device Dislodged or Dislocated 5 5
Structural Problem 4 4
Patient-Device Incompatibility 4 4
Component or Accessory Incompatibility 3 3
Improper or Incorrect Procedure or Method 3 3
Fitting Problem 3 3
Positioning Problem 3 3
Physical Resistance/Sticking 2 2
Inadequacy of Device Shape and/or Size 2 2
Product Quality Problem 2 2
Difficult to Remove 2 2
Loose or Intermittent Connection 2 2
Use of Device Problem 2 2
Defective Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Damaged by Another Device 1 1
Difficult to Advance 1 1
Malposition of Device 1 1
Separation Failure 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Misassembled 1 1
Loss of or Failure to Bond 1 1
Crack 1 1
Disconnection 1 1
Solder Joint Fracture 1 1
Inadequate or Insufficient Training 1 1
Noise, Audible 1 1
Misassembly by Users 1 1
Output Problem 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 179 179
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 112 112
Pain 91 91
Insufficient Information 87 87
No Code Available 74 74
Failure of Implant 73 73
Nerve Damage 71 71
Non-union Bone Fracture 70 70
Post Operative Wound Infection 66 66
No Known Impact Or Consequence To Patient 56 56
Unspecified Tissue Injury 50 50
Osteolysis 47 47
Unspecified Infection 46 46
Bone Fracture(s) 35 35
No Consequences Or Impact To Patient 34 34
Hematoma 30 30
Perforation of Vessels 28 28
Joint Laxity 28 28
Intervertebral Disc Compression or Protrusion 24 24
Cerebrospinal Fluid Leakage 22 22
Physical Asymmetry 20 20
Decreased Sensitivity 17 17
Foreign Body In Patient 17 17
No Information 16 16
Vertebral Fracture 16 16
Spinal Cord Injury 13 13
Impaired Healing 11 11
Neuralgia 10 10
Limited Mobility Of The Implanted Joint 10 10
Injury 9 9
Malunion of Bone 9 9
Neck Pain 8 8
Joint Disorder 8 8
Discomfort 7 7
Necrosis 7 7
Loss of Range of Motion 6 6
Device Embedded In Tissue or Plaque 6 6
Not Applicable 5 5
Hemorrhage/Bleeding 5 5
Implant Pain 5 5
Spinal Column Injury 4 4
Thromboembolism 4 4
Unspecified Nervous System Problem 4 4
Thrombosis/Thrombus 3 3
Ambulation Difficulties 3 3
Seroma 3 3
Neurological Deficit/Dysfunction 3 3
Muscular Rigidity 2 2
Wound Dehiscence 2 2
Fall 2 2
Fatigue 2 2
Synovitis 2 2
Stenosis 2 2
Numbness 2 2
Unspecified Kidney or Urinary Problem 2 2
Embolism/Embolus 1 1
Balance Problems 1 1
Patient Problem/Medical Problem 1 1
Vascular Dissection 1 1
Respiratory Tract Infection 1 1
Complaint, Ill-Defined 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1
Cognitive Changes 1 1
No Patient Involvement 1 1
Visual Impairment 1 1
Weakness 1 1
Thrombosis 1 1
Urinary Tract Infection 1 1
Swelling 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
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
-
-