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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device appliance, fixation, spinal interlaminal
Product CodeKWP
Regulation Number 888.3050
Device Class 2

MDR Year MDR Reports MDR Events
2018 657 657
2019 518 518
2020 796 796
2021 529 529
2022 337 337

Device Problems MDRs with this Device Problem Events in those MDRs
Break 898 898
Adverse Event Without Identified Device or Use Problem 335 335
Device Slipped 247 247
Failure to Align 220 220
Migration 197 197
Material Deformation 171 171
Loosening of Implant Not Related to Bone-Ingrowth 162 162
Migration or Expulsion of Device 130 130
Fracture 110 110
Device Dislodged or Dislocated 98 98
Loose or Intermittent Connection 58 58
Mechanical Problem 38 38
Detachment of Device or Device Component 34 34
Mechanics Altered 29 29
Device-Device Incompatibility 28 28
No Apparent Adverse Event 24 24
Malposition of Device 22 22
Material Integrity Problem 21 21
Mechanical Jam 21 21
Material Twisted/Bent 17 17
Appropriate Term/Code Not Available 17 17
Device Damaged by Another Device 15 15
Use of Device Problem 14 14
Material Fragmentation 10 10
Detachment Of Device Component 10 10
Material Erosion 9 9
Biocompatibility 8 8
Crack 8 8
Insufficient Information 8 8
Packaging Problem 8 8
Expulsion 8 8
Unintended Movement 7 7
Torn Material 7 7
Naturally Worn 7 7
Metal Shedding Debris 6 6
Entrapment of Device 6 6
Scratched Material 6 6
Patient-Device Incompatibility 6 6
Material Disintegration 5 5
Defective Component 5 5
Material Split, Cut or Torn 5 5
Improper or Incorrect Procedure or Method 4 4
Bent 4 4
Material Separation 4 4
Patient Device Interaction Problem 4 4
Device Operational Issue 3 3
Material Protrusion/Extrusion 3 3
Failure to Advance 3 3
Peeled/Delaminated 3 3
Osseointegration Problem 3 3
Difficult to Insert 3 3
Connection Problem 3 3
Device Markings/Labelling Problem 3 3
Difficult to Advance 2 2
Flaked 2 2
Ejection Problem 2 2
Inadequate Instructions for Healthcare Professional 2 2
Component Missing 2 2
Degraded 2 2
Difficult to Open or Close 2 2
Nonstandard Device 2 2
Defective Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Inoperable 2 2
Corroded 2 2
Compatibility Problem 2 2
Positioning Failure 2 2
Inaccurate Information 2 2
Device Handling Problem 1 1
Inadequate or Insufficient Training 1 1
Device Issue 1 1
Separation Failure 1 1
Device Operates Differently Than Expected 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Contamination with Chemical or Other Material 1 1
Tear, Rip or Hole in Device Packaging 1 1
Leak/Splash 1 1
Misconnection 1 1
Unstable 1 1
Product Quality Problem 1 1
Device Fell 1 1
Activation, Positioning or Separation Problem 1 1
Difficult To Position 1 1
Unintended Ejection 1 1
Collapse 1 1
Therapeutic or Diagnostic Output Failure 1 1
Noise, Audible 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Component Misassembled 1 1
Unintended System Motion 1 1
Device Damaged Prior to Use 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 938 938
No Clinical Signs, Symptoms or Conditions 627 627
Pain 395 395
Failure of Implant 155 155
No Code Available 137 137
No Consequences Or Impact To Patient 107 107
Seroma 66 66
Unspecified Infection 65 65
Device Embedded In Tissue or Plaque 65 65
Injury 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 60 60
Bone Fracture(s) 50 50
No Patient Involvement 44 44
Insufficient Information 36 36
Foreign Body In Patient 33 33
No Information 32 32
Spinal Column Injury 32 32
Post Operative Wound Infection 30 30
Stenosis 30 30
Discomfort 29 29
Paralysis 22 22
Patient Problem/Medical Problem 20 20
Neurological Deficit/Dysfunction 20 20
Non-union Bone Fracture 19 19
Numbness 18 18
Neck Pain 18 18
Ambulation Difficulties 15 15
Not Applicable 15 15
Spinal Cord Injury 15 15
Weakness 14 14
Nerve Damage 14 14
Reaction 13 13
Fall 13 13
Unspecified Nervous System Problem 11 11
Disability 10 10
Neuropathy 10 10
Cerebrospinal Fluid Leakage 9 9
Burning Sensation 9 9
Hematoma 9 9
Swelling 7 7
Unspecified Tissue Injury 7 7
Hemorrhage/Bleeding 7 7
Purulent Discharge 7 7
Ossification 6 6
Arthritis 6 6
Hypersensitivity/Allergic reaction 6 6
Low Blood Pressure/ Hypotension 6 6
Inflammation 6 6
Osteolysis 5 5
Foreign Body Reaction 5 5
Necrosis 5 5
Rupture 5 5
Pressure Sores 5 5
Fever 4 4
Muscle Weakness 4 4
Headache 4 4
Dizziness 4 4
Blood Loss 4 4
Inadequate Osseointegration 4 4
Death 4 4
Joint Laxity 4 4
Movement Disorder 3 3
Inadequate Pain Relief 3 3
Nausea 3 3
Tingling 3 3
Brain Injury 3 3
Loss of Range of Motion 3 3
Respiratory Failure 3 3
Muscle Spasm(s) 3 3
Cyst(s) 3 3
Thrombosis 3 3
Undesired Nerve Stimulation 3 3
Complaint, Ill-Defined 3 3
Anxiety 3 3
Skin Discoloration 3 3
Rash 2 2
Staphylococcus Aureus 2 2
Sepsis 2 2
Fatigue 2 2
Wound Dehiscence 2 2
Abscess 2 2
Ulcer 2 2
Thrombus 2 2
Perforation of Vessels 2 2
Osteopenia/ Osteoporosis 2 2
Decreased Sensitivity 2 2
Sleep Dysfunction 2 2
Deformity/ Disfigurement 2 2
Perforation of Esophagus 2 2
Spinal Arachnoiditis 2 2
Shaking/Tremors 2 2
Depression 2 2
Impaired Healing 2 2
Cardiac Arrest 2 2
Unspecified Musculoskeletal problem 2 2
Pulmonary Embolism 2 2
Embolism/Embolus 2 2
Intervertebral Disc Compression or Protrusion 2 2
Stroke/CVA 2 2
Infarction, Cerebral 2 2

Recalls
Manufacturer Recall Class Date Posted
1 K2M, Inc II Mar-01-2022
2 K2M, Inc. II Jun-30-2022
3 Medicrea International II Mar-11-2020
4 Medicrea International II Jan-24-2020
5 Medtronic Sofamor Danek USA Inc II May-08-2020
6 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-11-2018
7 Zimmer Biomet Spine Inc. II Feb-22-2019
8 Zimmer Biomet, Inc. II Jun-05-2019
9 ulrich medical USA Inc II Mar-02-2020
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