• 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, spondylolisthesis spinal fixation
Product CodeMNH
Regulation Number 888.3070
Device Class 2

MDR Year MDR Reports MDR Events
2017 174 174
2018 129 129
2019 403 403
2020 442 442
2021 536 536

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 665 665
Break 241 241
No Apparent Adverse Event 122 122
Migration 91 91
Loose or Intermittent Connection 85 85
Device Slipped 75 75
Unintended Movement 72 72
Fracture 55 55
Migration or Expulsion of Device 54 54
Appropriate Term/Code Not Available 52 52
Device-Device Incompatibility 43 43
Material Integrity Problem 36 36
Patient Device Interaction Problem 32 32
Material Deformation 30 30
Mechanical Problem 27 27
Device Dislodged or Dislocated 23 23
Material Twisted/Bent 23 23
Loosening of Implant Not Related to Bone-Ingrowth 23 23
Insufficient Information 20 20
Detachment of Device or Device Component 20 20
Material Separation 13 13
Device Operates Differently Than Expected 11 11
Detachment Of Device Component 10 10
Entrapment of Device 9 9
Compatibility Problem 7 7
Mechanical Jam 7 7
Physical Resistance/Sticking 7 7
Fitting Problem 6 6
Crack 5 5
Material Split, Cut or Torn 5 5
Positioning Problem 5 5
Noise, Audible 4 4
Disassembly 4 4
Corroded 4 4
Difficult to Advance 4 4
Malposition of Device 3 3
Component Missing 3 3
Physical Property Issue 3 3
Mechanics Altered 3 3
Improper or Incorrect Procedure or Method 3 3
Material Protrusion/Extrusion 3 3
Structural Problem 2 2
Patient-Device Incompatibility 2 2
Disconnection 2 2
Material Fragmentation 2 2
Inflation Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Appears to Trigger Rejection 1 1
Display or Visual Feedback Problem 1 1
Partial Blockage 1 1
Activation, Positioning or SeparationProblem 1 1
Device Damaged by Another Device 1 1
Failure to Align 1 1
Defective Device 1 1
Incomplete or Missing Packaging 1 1
Dull, Blunt 1 1
Defective Component 1 1
Device Inoperable 1 1
Output Problem 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 486 486
Pain 219 219
No Clinical Signs, Symptoms or Conditions 150 150
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 132 132
No Known Impact Or Consequence To Patient 130 130
Failure of Implant 114 114
Injury 111 111
Insufficient Information 101 101
Unspecified Infection 99 99
Non-union Bone Fracture 85 85
No Consequences Or Impact To Patient 80 80
Bone Fracture(s) 76 76
Neurological Deficit/Dysfunction 70 70
Nerve Damage 60 60
Post Operative Wound Infection 53 53
Hypoesthesia 44 44
Hematoma 34 34
Unspecified Tissue Injury 32 32
Paralysis 30 30
Cerebrospinal Fluid Leakage 25 25
Impaired Healing 24 24
Osteolysis 23 23
Weakness 20 20
No Patient Involvement 19 19
Dysphagia/ Odynophagia 18 18
Spinal Cord Injury 17 17
Physical Asymmetry 17 17
Death 16 16
Discomfort 11 11
No Information 10 10
Seroma 9 9
Spinal Column Injury 8 8
Wound Dehiscence 8 8
Device Embedded In Tissue or Plaque 8 8
Foreign Body In Patient 7 7
Hemorrhage/Bleeding 7 7
Stenosis 7 7
Thrombosis 6 6
Tissue Damage 6 6
Deformity/ Disfigurement 6 6
Loss of Range of Motion 6 6
Fall 6 6
Patient Problem/Medical Problem 6 6
Necrosis 5 5
Inflammation 5 5
Numbness 5 5
Perforation of Vessels 4 4
Skin Irritation 4 4
Hypersensitivity/Allergic reaction 4 4
Incontinence 4 4
Limited Mobility Of The Implanted Joint 4 4
Joint Laxity 3 3
Swelling/ Edema 3 3
Fatigue 3 3
Abscess 3 3
Neck Pain 3 3
Blood Loss 3 3
Reaction 2 2
Swelling 2 2
Burning Sensation 2 2
Tingling 2 2
Ossification 2 2
Bacterial Infection 2 2
Headache 2 2
Itching Sensation 2 2
Laceration(s) 2 2
Stroke/CVA 2 2
Pneumonia 2 2
Implant Pain 2 2
Intervertebral Disc Compression or Protrusion 2 2
Decreased Sensitivity 2 2
Inadequate Osseointegration 2 2
Thromboembolism 2 2
Ambulation Difficulties 2 2
Pseudoaneurysm 2 2
Fibrosis 1 1
Not Applicable 1 1
Constipation 1 1
Neuralgia 1 1
Heart Failure/Congestive Heart Failure 1 1
Vertebral Fracture 1 1
Skin Inflammation/ Irritation 1 1
Paresis 1 1
Nausea 1 1
Irritation 1 1
Purulent Discharge 1 1
Fever 1 1
Erosion 1 1
Bruise/Contusion 1 1
Calcium Deposits/Calcification 1 1
Pulmonary Embolism 1 1
Adhesion(s) 1 1
Arthritis 1 1
Cramp(s) 1 1
Rupture 1 1
Hernia 1 1
Pressure Sores 1 1
Complaint, Ill-Defined 1 1
Abdominal Distention 1 1
Respiratory Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 XTANT MEDICAL INC II Apr-27-2017
-
-