• 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 545 545
2022 233 233

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 770 770
Break 264 264
No Apparent Adverse Event 123 123
Loose or Intermittent Connection 111 111
Migration 107 107
Device Slipped 89 89
Unintended Movement 72 72
Migration or Expulsion of Device 63 63
Fracture 55 55
Appropriate Term/Code Not Available 53 53
Device-Device Incompatibility 49 49
Material Integrity Problem 46 46
Material Deformation 41 41
Patient Device Interaction Problem 39 39
Loosening of Implant Not Related to Bone-Ingrowth 33 33
Mechanical Problem 29 29
Device Dislodged or Dislocated 25 25
Material Twisted/Bent 24 24
Detachment of Device or Device Component 22 22
Insufficient Information 20 20
Material Separation 15 15
Device Operates Differently Than Expected 11 11
Compatibility Problem 11 11
Detachment Of Device Component 10 10
Entrapment of Device 9 9
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
Difficult to Advance 4 4
Material Protrusion/Extrusion 4 4
Noise, Audible 4 4
Disassembly 4 4
Corroded 4 4
Malposition of Device 3 3
Component Missing 3 3
Improper or Incorrect Procedure or Method 3 3
Physical Property Issue 3 3
Mechanics Altered 3 3
Output Problem 2 2
Structural Problem 2 2
Patient-Device Incompatibility 2 2
Defective Component 2 2
Difficult to Remove 2 2
Disconnection 2 2
Material Fragmentation 2 2
Inflation Problem 1 1
Fluid/Blood Leak 1 1
Device Appears to Trigger Rejection 1 1
Display or Visual Feedback Problem 1 1
Collapse 1 1
Partial Blockage 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Inoperable 1 1
Activation, Positioning or Separation Problem 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
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 486 486
Pain 282 282
No Clinical Signs, Symptoms or Conditions 202 202
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 170 170
Failure of Implant 135 135
No Known Impact Or Consequence To Patient 130 130
Insufficient Information 125 125
Non-union Bone Fracture 122 122
Injury 111 111
Unspecified Infection 107 107
Bone Fracture(s) 80 80
No Consequences Or Impact To Patient 80 80
Neurological Deficit/Dysfunction 70 70
Nerve Damage 68 68
Post Operative Wound Infection 64 64
Hypoesthesia 44 44
Hematoma 42 42
Unspecified Tissue Injury 41 41
Osteolysis 33 33
Paralysis 31 31
Cerebrospinal Fluid Leakage 30 30
Impaired Healing 25 25
Unspecified Nervous System Problem 24 24
Physical Asymmetry 23 23
Weakness 20 20
Dysphagia/ Odynophagia 20 20
No Patient Involvement 19 19
Spinal Cord Injury 18 18
Death 16 16
Discomfort 13 13
Perforation of Vessels 10 10
No Information 10 10
Foreign Body In Patient 9 9
Seroma 9 9
Spinal Column Injury 8 8
Deformity/ Disfigurement 8 8
Wound Dehiscence 8 8
Hemorrhage/Bleeding 8 8
Device Embedded In Tissue or Plaque 8 8
Numbness 8 8
Necrosis 7 7
Fall 7 7
Stenosis 7 7
Neck Pain 7 7
Loss of Range of Motion 6 6
Thrombosis 6 6
Tissue Damage 6 6
Patient Problem/Medical Problem 6 6
Joint Laxity 5 5
Fatigue 5 5
Muscular Rigidity 5 5
Inflammation 5 5
Incontinence 4 4
Hypersensitivity/Allergic reaction 4 4
Ossification 4 4
Abscess 4 4
Skin Irritation 4 4
Limited Mobility Of The Implanted Joint 4 4
Decreased Sensitivity 3 3
Blood Loss 3 3
Swelling/ Edema 3 3
Implant Pain 2 2
Unspecified Musculoskeletal problem 2 2
Pseudoaneurysm 2 2
Inadequate Osseointegration 2 2
Thromboembolism 2 2
Ambulation Difficulties 2 2
Intervertebral Disc Compression or Protrusion 2 2
Swelling 2 2
Pneumonia 2 2
Burning Sensation 2 2
Tingling 2 2
Reaction 2 2
Depression 2 2
Bacterial Infection 2 2
Pulmonary Embolism 2 2
Headache 2 2
Itching Sensation 2 2
Laceration(s) 2 2
Stroke/CVA 2 2
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
Cellulitis 1 1
Adhesion(s) 1 1
Anemia 1 1
Arthritis 1 1
Pressure Sores 1 1
Complaint, Ill-Defined 1 1
Inadequate Pain Relief 1 1
Cramp(s) 1 1
Urinary Tract Infection 1 1
Rupture 1 1
Hernia 1 1
Paresis 1 1
Respiratory Failure 1 1

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