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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 331 331
2024 237 237

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1059 1059
Adverse Event Without Identified Device or Use Problem 375 375
Device Slipped 300 300
Migration 227 227
Failure to Align 220 220
Loosening of Implant Not Related to Bone-Ingrowth 186 186
Material Deformation 183 183
Fracture 155 155
Device Dislodged or Dislocated 133 133
Migration or Expulsion of Device 130 130
Loose or Intermittent Connection 58 58
Detachment of Device or Device Component 52 52
Mechanical Problem 47 47
Device Appears to Trigger Rejection 46 46
Device-Device Incompatibility 38 38
Material Twisted/Bent 38 38
Mechanics Altered 36 36
No Apparent Adverse Event 29 29
Malposition of Device 28 28
Mechanical Jam 27 27
Material Integrity Problem 25 25
Appropriate Term/Code Not Available 22 22
Use of Device Problem 18 18
Device Damaged by Another Device 15 15
Patient-Device Incompatibility 12 12
Packaging Problem 12 12
Insufficient Information 11 11
Material Fragmentation 10 10
Detachment Of Device Component 10 10
Crack 10 10
Entrapment of Device 9 9
Material Erosion 9 9
Biocompatibility 9 9
Expulsion 8 8
Material Separation 8 8
Product Quality Problem 7 7
Compatibility Problem 7 7
Torn Material 7 7
Unintended Movement 7 7
Scratched Material 7 7
Naturally Worn 7 7
Patient Device Interaction Problem 6 6
Metal Shedding Debris 6 6
Defective Component 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Difficult to Advance 5 5
Material Disintegration 5 5
Material Split, Cut or Torn 5 5
Osseointegration Problem 4 4
Bent 4 4
Improper or Incorrect Procedure or Method 4 4
Connection Problem 3 3
Activation, Positioning or Separation Problem 3 3
Failure to Advance 3 3
Device Markings/Labelling Problem 3 3
Device Operational Issue 3 3
Material Protrusion/Extrusion 3 3
Difficult to Insert 3 3
Degraded 3 3
Peeled/Delaminated 3 3
Nonstandard Device 2 2
Flaked 2 2
Inadequacy of Device Shape and/or Size 2 2
Positioning Failure 2 2
Corroded 2 2
Inadequate Instructions for Healthcare Professional 2 2
Defective Device 2 2
Difficult to Open or Close 2 2
Device Inoperable 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
Component Misassembled 1 1
Positioning Problem 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
Unstable 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
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 906 906
Pain 487 487
Failure of Implant 203 203
No Code Available 137 137
No Consequences Or Impact To Patient 107 107
Unspecified Infection 86 86
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 74 74
Device Embedded In Tissue or Plaque 73 73
Insufficient Information 70 70
Seroma 67 67
Bone Fracture(s) 60 60
Injury 60 60
Implant Pain 51 51
No Patient Involvement 44 44
Spinal Column Injury 37 37
Foreign Body In Patient 36 36
Post Operative Wound Infection 35 35
Non-union Bone Fracture 34 34
Discomfort 33 33
No Information 32 32
Stenosis 31 31
Nerve Damage 24 24
Paralysis 23 23
Ambulation Difficulties 23 23
Neck Pain 21 21
Patient Problem/Medical Problem 20 20
Numbness 20 20
Neurological Deficit/Dysfunction 20 20
Spinal Cord Injury 16 16
Not Applicable 15 15
Weakness 14 14
Fall 14 14
Neuropathy 13 13
Reaction 13 13
Osteolysis 12 12
Hematoma 11 11
Hemorrhage/Bleeding 11 11
Unspecified Nervous System Problem 11 11
Joint Laxity 10 10
Disability 10 10
Burning Sensation 9 9
Cerebrospinal Fluid Leakage 9 9
Hypersensitivity/Allergic reaction 8 8
Inadequate Osseointegration 8 8
Swelling 7 7
Purulent Discharge 7 7
Unspecified Tissue Injury 7 7
Swelling/ Edema 6 6
Ossification 6 6
Arthritis 6 6
Low Blood Pressure/ Hypotension 6 6
Foreign Body Reaction 6 6
Inflammation 6 6
Necrosis 5 5
Rupture 5 5
Impaired Healing 5 5
Pressure Sores 5 5
Inadequate Pain Relief 4 4
Dizziness 4 4
Blood Loss 4 4
Loss of Range of Motion 4 4
Headache 4 4
Muscle Weakness 4 4
Fever 4 4
Death 4 4
Unspecified Musculoskeletal problem 4 4
Cyst(s) 3 3
Nausea 3 3
Muscle Spasm(s) 3 3
Undesired Nerve Stimulation 3 3
Sepsis 3 3
Thrombosis 3 3
Paraplegia 3 3
Respiratory Failure 3 3
Movement Disorder 3 3
Skin Discoloration 3 3
Tingling 3 3
Brain Injury 3 3
Anxiety 3 3
Complaint, Ill-Defined 3 3
Deformity/ Disfigurement 2 2
Depression 2 2
Perforation of Esophagus 2 2
Ulcer 2 2
Constipation 2 2
Decreased Sensitivity 2 2
Osteopenia/ Osteoporosis 2 2
Shaking/Tremors 2 2
Sleep Dysfunction 2 2
Electric Shock 2 2
Thrombus 2 2
Perforation of Vessels 2 2
Rash 2 2
Staphylococcus Aureus 2 2
Paresis 2 2
Stroke/CVA 2 2
Infarction, Cerebral 2 2
Cardiac Arrest 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 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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