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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


Premarket Reviews
ManufacturerDecision
BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
CG BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY INC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MIKRON MAKINA SANAYI TICARET CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION S.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 117 117
2017 246 246
2018 134 134
2019 188 188
2020 115 115
2021 237 237

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 319 319
Break 247 247
Fracture 93 93
Migration or Expulsion of Device 64 64
Loose or Intermittent Connection 43 43
Mechanical Problem 40 40
Material Integrity Problem 40 40
Device Dislodged or Dislocated 40 40
Migration 33 33
Material Separation 33 33
Device Slipped 28 28
Appropriate Term/Code Not Available 28 28
Unintended Movement 27 27
No Apparent Adverse Event 26 26
Detachment of Device or Device Component 25 25
Insufficient Information 23 23
Detachment Of Device Component 22 22
Device-Device Incompatibility 19 19
Device Operates Differently Than Expected 19 19
Material Fragmentation 16 16
Material Deformation 15 15
Failure To Adhere Or Bond 14 14
Material Twisted/Bent 13 13
Patient Device Interaction Problem 13 13
Loosening of Implant Not Related to Bone-Ingrowth 11 11
Noise, Audible 9 9
Entrapment of Device 9 9
Malposition of Device 9 9
Device Operational Issue 9 9
Disassembly 8 8
Compatibility Problem 7 7
Defective Device 7 7
Mechanical Jam 6 6
Device Damaged by Another Device 5 5
Improper or Incorrect Procedure or Method 5 5
Bent 5 5
Use of Device Problem 5 5
Structural Problem 4 4
Connection Problem 4 4
Defective Component 4 4
Fitting Problem 4 4
Failure to Align 4 4
Positioning Problem 4 4
Difficult to Insert 3 3
Difficult To Position 3 3
Torn Material 3 3
Component or Accessory Incompatibility 3 3
Difficult to Remove 3 3
Material Split, Cut or Torn 3 3
Metal Shedding Debris 2 2
Product Quality Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Packaging Problem 2 2
Crack 2 2
Device Damaged Prior to Use 2 2
Disconnection 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Markings/Labelling Problem 1 1
Calibration Problem 1 1
Output Problem 1 1
Inadequate or Insufficient Training 1 1
Separation Failure 1 1
Human Factors Issue 1 1
Material Torqued 1 1
Misassembly by Users 1 1
Physical Resistance/Sticking 1 1
Inadequacy of Device Shape and/or Size 1 1
Solder Joint Fracture 1 1
Measurement System Incompatibility 1 1
Component Missing 1 1
Loss of or Failure to Bond 1 1
Physical Property Issue 1 1
Misassembled 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 204 204
No Code Available 165 165
Failure of Implant 129 129
Pain 109 109
No Information 81 81
Injury 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 75 75
No Consequences Or Impact To Patient 62 62
Non-union Bone Fracture 38 38
Post Operative Wound Infection 36 36
Nerve Damage 32 32
Bone Fracture(s) 26 26
Unspecified Tissue Injury 26 26
Intervertebral Disc Compression or Protrusion 24 24
No Clinical Signs, Symptoms or Conditions 24 24
Unspecified Infection 23 23
Impaired Healing 22 22
Device Embedded In Tissue or Plaque 20 20
Foreign Body In Patient 19 19
Insufficient Information 19 19
Not Applicable 15 15
Discomfort 13 13
Perforation of Vessels 13 13
Spinal Column Injury 13 13
Limited Mobility Of The Implanted Joint 12 12
Osteolysis 12 12
Neuralgia 10 10
Spinal Cord Injury 10 10
Sedation 8 8
Joint Disorder 8 8
Sudden Cardiac Death 8 8
Physical Asymmetry 8 8
Malunion of Bone 7 7
Ambulation Difficulties 7 7
Cerebrospinal Fluid Leakage 7 7
Hematoma 6 6
Patient Problem/Medical Problem 6 6
Fall 5 5
Neurological Deficit/Dysfunction 4 4
Decreased Sensitivity 4 4
Implant Pain 3 3
No Patient Involvement 3 3
Weakness 3 3
Irritation 3 3
Fatigue 2 2
Hemorrhage/Bleeding 2 2
Hypersensitivity/Allergic reaction 2 2
Pulmonary Embolism 2 2
Perforation 2 2
Synovitis 2 2
Complaint, Ill-Defined 2 2
Necrosis 2 2
Thromboembolism 2 2
Numbness 2 2
Joint Laxity 2 2
Neck Pain 1 1
Hypoesthesia 1 1
Chills 1 1
Thrombosis 1 1
Visual Impairment 1 1
Excessive Tear Production 1 1
Stenosis 1 1
Pressure Sores 1 1
Anxiety 1 1
Positive antinuclear antibodies (ANA) 1 1
Rash 1 1
Scarring 1 1
Sepsis 1 1
Seroma 1 1
Swelling 1 1
Paralysis 1 1
Paresis 1 1
Arthritis 1 1
Death 1 1
Erythema 1 1
Fistula 1 1
Incontinence 1 1
Muscular Rigidity 1 1
Neuropathy 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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