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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 149 149

Device Problems MDRs with this Device Problem Events in those MDRs
Break 829 829
Adverse Event Without Identified Device or Use Problem 327 327
Device Slipped 259 259
Migration 191 191
Loosening of Implant Not Related to Bone-Ingrowth 176 176
Material Deformation 133 133
Device Dislodged or Dislocated 124 124
Fracture 111 111
Failure to Align 80 80
Migration or Expulsion of Device 74 74
Device Appears to Trigger Rejection 46 46
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 35 35
Mechanics Altered 30 30
No Apparent Adverse Event 29 29
Mechanical Jam 27 27
Malposition of Device 23 23
Material Integrity Problem 22 22
Device Damaged by Another Device 15 15
Use of Device Problem 15 15
Patient-Device Incompatibility 11 11
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 7 7
Patient Device Interaction Problem 6 6
Material Fragmentation 6 6
Product Quality Problem 6 6
Material Separation 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Difficult to Advance 4 4
Unintended Movement 4 4
Osseointegration Problem 4 4
Biocompatibility 3 3
Material Disintegration 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
Defective Device 2 2
Improper or Incorrect Procedure or Method 2 2
Nonstandard Device 2 2
Peeled/Delaminated 2 2
Inadequacy of Device Shape and/or Size 2 2
Connection Problem 2 2
Activation, Positioning or Separation Problem 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
Device Handling Problem 1 1
Noise, Audible 1 1
Positioning Problem 1 1
Device Markings/Labelling Problem 1 1
Material Protrusion/Extrusion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Too Rigid or Stiff 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
Inadequate or Insufficient Training 1 1
Unstable 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 851 851
No Known Impact Or Consequence To Patient 583 583
Pain 405 405
Failure of Implant 162 162
No Code Available 99 99
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 72 72
Unspecified Infection 66 66
Seroma 66 66
Device Embedded In Tissue or Plaque 63 63
Insufficient Information 62 62
Implant Pain 50 50
Bone Fracture(s) 49 49
Injury 41 41
No Patient Involvement 38 38
Non-union Bone Fracture 30 30
Foreign Body In Patient 29 29
Post Operative Wound Infection 28 28
Stenosis 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
Nerve Damage 18 18
Paralysis 18 18
Neurological Deficit/Dysfunction 17 17
Spinal Column Injury 17 17
Neck Pain 16 16
No Information 14 14
Spinal Cord Injury 13 13
Neuropathy 13 13
Fall 13 13
Osteolysis 12 12
Unspecified Nervous System Problem 11 11
Hematoma 11 11
Hemorrhage/Bleeding 10 10
Joint Laxity 10 10
Disability 9 9
Weakness 9 9
Burning Sensation 8 8
Purulent Discharge 7 7
Reaction 7 7
Unspecified Tissue Injury 7 7
Swelling/ Edema 6 6
Swelling 6 6
Inadequate Osseointegration 6 6
Cerebrospinal Fluid Leakage 6 6
Ossification 6 6
Arthritis 6 6
Low Blood Pressure/ Hypotension 6 6
Inflammation 6 6
Necrosis 5 5
Foreign Body Reaction 5 5
Impaired Healing 5 5
Rupture 4 4
Unspecified Musculoskeletal problem 4 4
Fever 4 4
Headache 4 4
Hypersensitivity/Allergic reaction 4 4
Loss of Range of Motion 4 4
Muscle Spasm(s) 3 3
Muscle Weakness 3 3
Nausea 3 3
Sepsis 3 3
Skin Discoloration 3 3
Thrombosis 3 3
Cyst(s) 3 3
Death 3 3
Movement Disorder 3 3
Blood Loss 3 3
Complaint, Ill-Defined 3 3
Pressure Sores 3 3
Anxiety 3 3
Dizziness 3 3
Paraplegia 3 3
Respiratory Failure 3 3
Shaking/Tremors 2 2
Inadequate Pain Relief 2 2
Perforation of Esophagus 2 2
Electric Shock 2 2
Osteopenia/ Osteoporosis 2 2
Spinal Arachnoiditis 2 2
Decreased Sensitivity 2 2
Constipation 2 2
Embolism/Embolus 2 2
Intervertebral Disc Compression or Protrusion 2 2
Cardiac Arrest 2 2
Pulmonary Embolism 2 2
Abscess 2 2
Wound Dehiscence 2 2
Fatigue 2 2
Stroke/CVA 2 2
Infarction, Cerebral 2 2
Thrombus 2 2
Tingling 2 2
Rash 2 2
Paresis 2 2
Pleural Effusion 1 1
Pneumonia 1 1
Pneumothorax 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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