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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 237 237

Device Problems MDRs with this Device Problem Events in those MDRs
Break 849 849
Adverse Event Without Identified Device or Use Problem 333 333
Device Slipped 265 265
Migration 196 196
Loosening of Implant Not Related to Bone-Ingrowth 178 178
Material Deformation 142 142
Device Dislodged or Dislocated 128 128
Fracture 121 121
Failure to Align 80 80
Migration or Expulsion of Device 74 74
Device Appears to Trigger Rejection 46 46
Mechanical Problem 43 43
Detachment of Device or Device Component 42 42
Loose or Intermittent Connection 39 39
Material Twisted/Bent 38 38
Device-Device Incompatibility 37 37
Mechanics Altered 36 36
No Apparent Adverse Event 29 29
Mechanical Jam 27 27
Material Integrity Problem 23 23
Malposition of Device 23 23
Use of Device Problem 16 16
Device Damaged by Another Device 15 15
Appropriate Term/Code Not Available 13 13
Patient-Device Incompatibility 11 11
Insufficient Information 10 10
Packaging Problem 9 9
Entrapment of Device 9 9
Crack 9 9
Material Separation 8 8
Expulsion 8 8
Compatibility Problem 7 7
Naturally Worn 7 7
Scratched Material 7 7
Product Quality Problem 6 6
Material Fragmentation 6 6
Patient Device Interaction Problem 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Difficult to Advance 5 5
Unintended Movement 4 4
Osseointegration Problem 4 4
Biocompatibility 3 3
Activation, Positioning or Separation Problem 3 3
Difficult to Insert 3 3
Material Disintegration 3 3
Degraded 3 3
Material Erosion 3 3
Failure to Advance 3 3
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
Corroded 2 2
Positioning Failure 2 2
Inadequate Instructions for Healthcare Professional 2 2
Connection 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
Material Protrusion/Extrusion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Markings/Labelling Problem 1 1
Leak/Splash 1 1
Misconnection 1 1
Material Discolored 1 1
Unintended Ejection 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 905 905
No Known Impact Or Consequence To Patient 583 583
Pain 421 421
Failure of Implant 165 165
No Code Available 99 99
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 74 74
Insufficient Information 70 70
Unspecified Infection 68 68
Seroma 66 66
Device Embedded In Tissue or Plaque 63 63
Bone Fracture(s) 51 51
Implant Pain 51 51
Injury 41 41
No Patient Involvement 38 38
Non-union Bone Fracture 32 32
Foreign Body In Patient 30 30
Post Operative Wound Infection 28 28
Stenosis 28 28
No Consequences Or Impact To Patient 25 25
Discomfort 24 24
Ambulation Difficulties 23 23
Spinal Column Injury 21 21
Numbness 19 19
Patient Problem/Medical Problem 19 19
Nerve Damage 18 18
Paralysis 18 18
Neurological Deficit/Dysfunction 17 17
Neck Pain 16 16
No Information 14 14
Fall 14 14
Neuropathy 13 13
Spinal Cord Injury 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
Hypersensitivity/Allergic reaction 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
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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