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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 336 336
2023 235 235

Device Problems MDRs with this Device Problem Events in those MDRs
Break 982 982
Adverse Event Without Identified Device or Use Problem 342 342
Device Slipped 292 292
Failure to Align 220 220
Migration 209 209
Material Deformation 174 174
Loosening of Implant Not Related to Bone-Ingrowth 167 167
Migration or Expulsion of Device 130 130
Device Dislodged or Dislocated 120 120
Fracture 117 117
Loose or Intermittent Connection 58 58
Mechanical Problem 40 40
Detachment of Device or Device Component 40 40
Device-Device Incompatibility 39 39
Material Twisted/Bent 30 30
Mechanics Altered 29 29
Malposition of Device 27 27
No Apparent Adverse Event 27 27
Mechanical Jam 23 23
Material Integrity Problem 21 21
Appropriate Term/Code Not Available 19 19
Use of Device Problem 16 16
Device Damaged by Another Device 15 15
Packaging Problem 11 11
Material Fragmentation 10 10
Detachment Of Device Component 10 10
Crack 9 9
Entrapment of Device 9 9
Material Erosion 9 9
Expulsion 8 8
Biocompatibility 8 8
Insufficient Information 8 8
Torn Material 7 7
Unintended Movement 7 7
Compatibility Problem 7 7
Naturally Worn 7 7
Patient-Device Incompatibility 6 6
Metal Shedding Debris 6 6
Scratched Material 6 6
Material Split, Cut or Torn 5 5
Defective Component 5 5
Material Disintegration 5 5
Material Separation 5 5
Bent 4 4
Improper or Incorrect Procedure or Method 4 4
Osseointegration Problem 4 4
Patient Device Interaction Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Connection Problem 3 3
Failure to Advance 3 3
Material Protrusion/Extrusion 3 3
Difficult to Advance 3 3
Device Operational Issue 3 3
Device Markings/Labelling Problem 3 3
Difficult to Insert 3 3
Degraded 3 3
Peeled/Delaminated 3 3
Nonstandard Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Product Quality Problem 2 2
Device Inoperable 2 2
Positioning Failure 2 2
Corroded 2 2
Inadequate Instructions for Healthcare Professional 2 2
Difficult to Open or Close 2 2
Flaked 2 2
Defective Device 2 2
Activation, Positioning or Separation Problem 2 2
Component Missing 2 2
Therapeutic or Diagnostic Output Failure 2 2
Ejection Problem 2 2
Inaccurate Information 2 2
Device Fell 1 1
Positioning Problem 1 1
Component Misassembled 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Damaged Prior to Use 1 1
Separation Failure 1 1
Device Contamination with Chemical or Other Material 1 1
Device Operates Differently Than Expected 1 1
Device Contaminated During Manufacture or Shipping 1 1
Leak/Splash 1 1
Unintended Ejection 1 1
Collapse 1 1
Material Discolored 1 1
Unstable 1 1
Inadequate or Insufficient Training 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Unintended System Motion 1 1
Difficult To Position 1 1
Misconnection 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 752 752
Pain 435 435
Failure of Implant 180 180
No Code Available 137 137
No Consequences Or Impact To Patient 107 107
Device Embedded In Tissue or Plaque 70 70
Unspecified Infection 70 70
Seroma 67 67
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 66 66
Injury 60 60
Bone Fracture(s) 55 55
No Patient Involvement 44 44
Insufficient Information 44 44
Foreign Body In Patient 34 34
Discomfort 33 33
Spinal Column Injury 33 33
No Information 32 32
Post Operative Wound Infection 31 31
Stenosis 30 30
Non-union Bone Fracture 27 27
Paralysis 23 23
Neck Pain 21 21
Patient Problem/Medical Problem 20 20
Neurological Deficit/Dysfunction 20 20
Numbness 19 19
Nerve Damage 18 18
Spinal Cord Injury 16 16
Ambulation Difficulties 15 15
Not Applicable 15 15
Weakness 14 14
Reaction 13 13
Fall 13 13
Hemorrhage/Bleeding 11 11
Unspecified Nervous System Problem 11 11
Hematoma 10 10
Neuropathy 10 10
Disability 10 10
Burning Sensation 9 9
Cerebrospinal Fluid Leakage 9 9
Inadequate Osseointegration 8 8
Purulent Discharge 7 7
Swelling 7 7
Unspecified Tissue Injury 7 7
Inflammation 6 6
Ossification 6 6
Arthritis 6 6
Hypersensitivity/Allergic reaction 6 6
Low Blood Pressure/ Hypotension 6 6
Foreign Body Reaction 6 6
Osteolysis 6 6
Pressure Sores 5 5
Rupture 5 5
Necrosis 5 5
Muscle Weakness 4 4
Loss of Range of Motion 4 4
Fever 4 4
Death 4 4
Headache 4 4
Dizziness 4 4
Inadequate Pain Relief 4 4
Blood Loss 4 4
Swelling/ Edema 4 4
Joint Laxity 4 4
Movement Disorder 3 3
Paraplegia 3 3
Respiratory Failure 3 3
Anxiety 3 3
Complaint, Ill-Defined 3 3
Brain Injury 3 3
Tingling 3 3
Cyst(s) 3 3
Sepsis 3 3
Skin Discoloration 3 3
Thrombosis 3 3
Nausea 3 3
Muscle Spasm(s) 3 3
Undesired Nerve Stimulation 3 3
Thrombus 2 2
Rash 2 2
Staphylococcus Aureus 2 2
Stroke/CVA 2 2
Infarction, Cerebral 2 2
Cardiac Arrest 2 2
Pulmonary Embolism 2 2
Abscess 2 2
Fatigue 2 2
Wound Dehiscence 2 2
Perforation of Vessels 2 2
Ulcer 2 2
Deformity/ Disfigurement 2 2
Depression 2 2
Perforation of Esophagus 2 2
Impaired Healing 2 2
Osteopenia/ Osteoporosis 2 2
Shaking/Tremors 2 2
Sleep Dysfunction 2 2
Constipation 2 2
Electric Shock 2 2
Decreased Sensitivity 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 Apr-19-2023
6 Medtronic Sofamor Danek USA Inc II May-08-2020
7 RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) II Oct-11-2018
8 Zimmer Biomet Spine Inc. II Feb-22-2019
9 Zimmer Biomet, Inc. II Jun-05-2019
10 ulrich medical USA Inc II Mar-02-2020
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