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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
2017 863 863
2018 657 657
2019 518 518
2020 796 796
2021 529 529
2022 293 293

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1184 1184
Adverse Event Without Identified Device or Use Problem 408 408
Failure to Align 349 349
Migration or Expulsion of Device 290 290
Device Slipped 245 245
Material Deformation 206 206
Migration 194 194
Fracture 168 168
Loosening of Implant Not Related to Bone-Ingrowth 159 159
Device Dislodged or Dislocated 118 118
Loose or Intermittent Connection 92 92
Mechanical Problem 64 64
Material Integrity Problem 52 52
Metal Shedding Debris 37 37
Detachment of Device or Device Component 37 37
Detachment Of Device Component 36 36
Appropriate Term/Code Not Available 34 34
Malposition of Device 33 33
Mechanics Altered 29 29
Device-Device Incompatibility 27 27
Mechanical Jam 26 26
No Apparent Adverse Event 24 24
Device Damaged by Another Device 18 18
Material Twisted/Bent 17 17
Insufficient Information 14 14
Unintended Movement 14 14
Material Fragmentation 14 14
Device Operates Differently Than Expected 12 12
Use of Device Problem 12 12
Material Erosion 9 9
Naturally Worn 9 9
Expulsion 8 8
Torn Material 8 8
Crack 8 8
Patient-Device Incompatibility 8 8
Biocompatibility 8 8
Improper or Incorrect Procedure or Method 7 7
Difficult to Remove 7 7
Bent 7 7
Entrapment of Device 7 7
Peeled/Delaminated 7 7
Noise, Audible 7 7
Packaging Problem 7 7
Scratched Material 6 6
Material Separation 6 6
Device Inoperable 6 6
Defective Component 5 5
Device Operational Issue 5 5
Material Disintegration 5 5
Material Split, Cut or Torn 5 5
Device Handling Problem 4 4
Patient Device Interaction Problem 4 4
Positioning Problem 4 4
Material Protrusion/Extrusion 4 4
Disconnection 4 4
Difficult to Insert 4 4
Device Markings/Labelling Problem 4 4
Connection Problem 4 4
Failure to Advance 4 4
Difficult to Open or Close 3 3
Incomplete or Missing Packaging 3 3
Nonstandard Device 3 3
Disassembly 3 3
Corroded 3 3
Contamination 2 2
Degraded 2 2
Positioning Failure 2 2
Failure To Adhere Or Bond 2 2
Collapse 2 2
Unintended System Motion 2 2
Unsealed Device Packaging 2 2
Inadequate Instructions for Healthcare Professional 2 2
Flaked 2 2
Component Missing 2 2
Out-Of-Box Failure 2 2
Inadequacy of Device Shape and/or Size 2 2
Unstable 2 2
Tear, Rip or Hole in Device Packaging 2 2
Defective Device 2 2
Device Contamination with Chemical or Other Material 2 2
Compatibility Problem 2 2
Osseointegration Problem 2 2
Ejection Problem 2 2
Inaccurate Information 2 2
Device Fell 1 1
Component Misassembled 1 1
Missing Value Reason 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Separation Failure 1 1
Activation, Positioning or Separation Problem 1 1
Battery Problem 1 1
Device Packaging Compromised 1 1
Stretched 1 1
Inadequate or Insufficient Training 1 1
Shelf Life Exceeded 1 1
Material Too Rigid or Stiff 1 1
Device Damaged Prior to Use 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1329 1329
No Clinical Signs, Symptoms or Conditions 603 603
Pain 511 511
No Code Available 364 364
Failure of Implant 206 206
No Consequences Or Impact To Patient 145 145
Injury 115 115
Unspecified Infection 93 93
No Information 74 74
Device Embedded In Tissue or Plaque 72 72
Seroma 66 66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 60 60
Bone Fracture(s) 59 59
No Patient Involvement 48 48
Foreign Body In Patient 38 38
Post Operative Wound Infection 35 35
Insufficient Information 35 35
Discomfort 34 34
Stenosis 32 32
Spinal Column Injury 32 32
Neck Pain 31 31
Numbness 30 30
Reaction 29 29
Non-union Bone Fracture 25 25
Patient Problem/Medical Problem 24 24
Paralysis 24 24
Neurological Deficit/Dysfunction 21 21
Neuropathy 18 18
Ambulation Difficulties 18 18
Not Applicable 15 15
Spinal Cord Injury 15 15
Weakness 15 15
Fall 15 15
Nerve Damage 14 14
Unspecified Nervous System Problem 11 11
Cerebrospinal Fluid Leakage 10 10
Burning Sensation 10 10
Disability 10 10
Inflammation 9 9
Swelling 8 8
Pressure Sores 8 8
Hypersensitivity/Allergic reaction 7 7
Purulent Discharge 7 7
Hematoma 7 7
Hemorrhage/Bleeding 6 6
Ossification 6 6
Arthritis 6 6
Low Blood Pressure/ Hypotension 6 6
Unspecified Tissue Injury 6 6
Muscle Spasm(s) 5 5
Headache 5 5
Necrosis 5 5
Fever 5 5
Foreign Body Reaction 5 5
Tingling 5 5
Rupture 5 5
Blood Loss 5 5
Osteolysis 5 5
Dizziness 4 4
Complaint, Ill-Defined 4 4
Wound Dehiscence 4 4
Cyst(s) 4 4
Death 4 4
Abscess 4 4
Muscle Weakness 4 4
Undesired Nerve Stimulation 4 4
Loss of Range of Motion 4 4
Staphylococcus Aureus 3 3
Nausea 3 3
Cardiac Arrest 3 3
Skin Discoloration 3 3
Anxiety 3 3
Brain Injury 3 3
Thrombosis 3 3
Impaired Healing 3 3
Inadequate Pain Relief 3 3
Depression 3 3
Respiratory Failure 3 3
Electric Shock 3 3
Inadequate Osseointegration 3 3
Movement Disorder 3 3
Spinal Arachnoiditis 2 2
Constipation 2 2
Unspecified Musculoskeletal problem 2 2
Embolism/Embolus 2 2
Intervertebral Disc Compression or Protrusion 2 2
Implant Pain 2 2
Swelling/ Edema 2 2
Osteopenia/ Osteoporosis 2 2
Decreased Sensitivity 2 2
Shaking/Tremors 2 2
Sleep Dysfunction 2 2
Perforation of Esophagus 2 2
Thrombus 2 2
Perforation of Vessels 2 2
Ulcer 2 2
Hypoesthesia 2 2
Deformity/ Disfigurement 2 2
Bacterial Infection 2 2
Pulmonary Embolism 2 2

Recalls
Manufacturer Recall Class Date Posted
1 K2M, Inc II Mar-01-2022
2 K2M, Inc. II Jun-30-2022
3 Medacta Usa Inc II Jan-13-2017
4 Medicrea International II Mar-11-2020
5 Medicrea International II Jan-24-2020
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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