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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
2019 518 518
2020 796 796
2021 529 529
2022 336 336
2023 331 331
2024 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Break 815 815
Adverse Event Without Identified Device or Use Problem 325 325
Device Slipped 257 257
Migration 187 187
Loosening of Implant Not Related to Bone-Ingrowth 166 166
Material Deformation 133 133
Device Dislodged or Dislocated 119 119
Fracture 104 104
Failure to Align 80 80
Migration or Expulsion of Device 74 74
Loose or Intermittent Connection 39 39
Mechanical Problem 38 38
Material Twisted/Bent 38 38
Device-Device Incompatibility 37 37
Detachment of Device or Device Component 34 34
Mechanics Altered 30 30
No Apparent Adverse Event 27 27
Mechanical Jam 27 27
Malposition of Device 22 22
Material Integrity Problem 20 20
Device Damaged by Another Device 15 15
Use of Device Problem 14 14
Appropriate Term/Code Not Available 11 11
Insufficient Information 9 9
Packaging Problem 9 9
Entrapment of Device 9 9
Crack 9 9
Expulsion 8 8
Compatibility Problem 7 7
Naturally Worn 7 7
Scratched Material 6 6
Patient Device Interaction Problem 6 6
Material Fragmentation 6 6
Product Quality Problem 6 6
Material Separation 5 5
Patient-Device Incompatibility 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Unintended Movement 4 4
Osseointegration Problem 4 4
Material Disintegration 3 3
Difficult to Advance 3 3
Failure to Advance 3 3
Difficult to Insert 3 3
Degraded 3 3
Material Erosion 3 3
Corroded 2 2
Positioning Failure 2 2
Inadequate Instructions for Healthcare Professional 2 2
Biocompatibility 2 2
Connection Problem 2 2
Activation, Positioning or Separation Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Inadequacy of Device Shape and/or Size 2 2
Nonstandard Device 2 2
Peeled/Delaminated 2 2
Defective Device 2 2
Difficult to Open or Close 2 2
Therapeutic or Diagnostic Output Failure 2 2
Ejection Problem 2 2
Device Fell 1 1
Component Misassembled 1 1
Positioning Problem 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Device Markings/Labelling Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Protrusion/Extrusion 1 1
Device Appears to Trigger Rejection 1 1
Material Too Rigid or Stiff 1 1
Inadequate or Insufficient Training 1 1
Unstable 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Leak/Splash 1 1
Misconnection 1 1
Material Discolored 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 824 824
No Known Impact Or Consequence To Patient 583 583
Pain 399 399
Failure of Implant 147 147
No Code Available 99 99
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 71 71
Seroma 66 66
Unspecified Infection 66 66
Device Embedded In Tissue or Plaque 61 61
Insufficient Information 58 58
Bone Fracture(s) 48 48
Injury 41 41
No Patient Involvement 38 38
Non-union Bone Fracture 30 30
Foreign Body In Patient 29 29
Stenosis 28 28
Post Operative Wound Infection 28 28
No Consequences Or Impact To Patient 25 25
Discomfort 24 24
Ambulation Difficulties 23 23
Patient Problem/Medical Problem 19 19
Numbness 18 18
Paralysis 18 18
Nerve Damage 18 18
Neurological Deficit/Dysfunction 17 17
Spinal Column Injury 17 17
Neck Pain 16 16
No Information 14 14
Fall 13 13
Neuropathy 13 13
Spinal Cord Injury 13 13
Osteolysis 12 12
Hematoma 11 11
Unspecified Nervous System Problem 11 11
Joint Laxity 10 10
Hemorrhage/Bleeding 10 10
Disability 9 9
Weakness 9 9
Burning Sensation 8 8
Reaction 7 7
Unspecified Tissue Injury 7 7
Purulent Discharge 7 7
Cerebrospinal Fluid Leakage 6 6
Swelling/ Edema 6 6
Low Blood Pressure/ Hypotension 6 6
Swelling 6 6
Inflammation 6 6
Arthritis 6 6
Inadequate Osseointegration 6 6
Ossification 6 6
Impaired Healing 5 5
Foreign Body Reaction 5 5
Necrosis 5 5
Hypersensitivity/Allergic reaction 4 4
Fever 4 4
Rupture 4 4
Headache 4 4
Loss of Range of Motion 4 4
Unspecified Musculoskeletal problem 4 4
Anxiety 3 3
Complaint, Ill-Defined 3 3
Skin Discoloration 3 3
Muscle Weakness 3 3
Sepsis 3 3
Muscle Spasm(s) 3 3
Thrombosis 3 3
Cyst(s) 3 3
Death 3 3
Nausea 3 3
Movement Disorder 3 3
Paraplegia 3 3
Dizziness 3 3
Blood Loss 3 3
Pressure Sores 3 3
Respiratory Failure 3 3
Intervertebral Disc Compression or Protrusion 2 2
Infarction, Cerebral 2 2
Tingling 2 2
Inadequate Pain Relief 2 2
Electric Shock 2 2
Abscess 2 2
Wound Dehiscence 2 2
Decreased Sensitivity 2 2
Rash 2 2
Osteopenia/ Osteoporosis 2 2
Thrombus 2 2
Spinal Arachnoiditis 2 2
Shaking/Tremors 2 2
Cardiac Arrest 2 2
Implant Pain 2 2
Stroke/CVA 2 2
Constipation 2 2
Paresis 2 2
Embolism/Embolus 2 2
Pulmonary Embolism 2 2
Fatigue 2 2
Perforation of Esophagus 2 2
Aortic Valve Stenosis 1 1
Ulcer 1 1
Joint Dislocation 1 1

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 Apr-19-2023
6 Medtronic Sofamor Danek USA Inc II May-08-2020
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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