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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
Regulation Description Spinal interlaminal fixation orthosis.
Product CodeKWP
Regulation Number 888.3050
Device Class 2

MDR Year MDR Reports MDR Events
2020 796 796
2021 525 525
2022 336 336
2023 332 332
2024 437 437
2025 173 173

Device Problems MDRs with this Device Problem Events in those MDRs
Break 780 780
Adverse Event Without Identified Device or Use Problem 307 307
Device Slipped 264 264
Loosening of Implant Not Related to Bone-Ingrowth 187 187
Material Deformation 165 165
Migration 157 157
Device Dislodged or Dislocated 142 142
Fracture 123 123
Mechanics Altered 52 52
Detachment of Device or Device Component 50 50
Device Appears to Trigger Rejection 46 46
Migration or Expulsion of Device 44 44
Device-Device Incompatibility 38 38
Mechanical Problem 38 38
Material Twisted/Bent 35 35
Mechanical Jam 30 30
No Apparent Adverse Event 29 29
Loose or Intermittent Connection 25 25
Malposition of Device 23 23
Failure to Align 22 22
Material Integrity Problem 21 21
Use of Device Problem 20 20
Device Damaged by Another Device 17 17
Unstable 14 14
Patient-Device Incompatibility 12 12
Appropriate Term/Code Not Available 10 10
Failure to Osseointegrate 10 10
Entrapment of Device 9 9
Packaging Problem 9 9
Material Separation 9 9
Expulsion 8 8
Patient Device Interaction Problem 8 8
Compatibility Problem 8 8
Crack 8 8
Degraded 7 7
Insufficient Information 7 7
Product Quality Problem 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Scratched Material 6 6
Difficult to Advance 5 5
Biocompatibility 4 4
Material Fragmentation 4 4
Unintended Movement 4 4
Osseointegration Problem 3 3
Activation, Positioning or Separation Problem 3 3
Corroded 3 3
Difficult to Insert 3 3
Failure to Advance 3 3
Material Erosion 3 3
Inadequacy of Device Shape and/or Size 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1135 1135
Pain 369 369
No Known Impact Or Consequence To Patient 291 291
Failure of Implant 159 159
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 78 78
Insufficient Information 71 71
Seroma 68 68
Implant Pain 66 66
Device Embedded In Tissue or Plaque 61 61
Unspecified Infection 58 58
Bone Fracture(s) 55 55
No Code Available 55 55
No Patient Involvement 38 38
Post Operative Wound Infection 35 35
Injury 35 35
Non-union Bone Fracture 35 35
Foreign Body In Patient 34 34
Ambulation Difficulties 25 25
Stenosis 23 23
Inadequate Osseointegration 23 23
Numbness 23 23
Spinal Column Injury 19 19
No Consequences Or Impact To Patient 19 19
Paralysis 18 18
Nerve Damage 18 18
Spinal Cord Injury 18 18
Patient Problem/Medical Problem 18 18
Neck Pain 16 16
Neurological Deficit/Dysfunction 16 16
Unspecified Nervous System Problem 15 15
Discomfort 14 14
Fall 12 12
Unspecified Tissue Injury 12 12
Osteolysis 11 11
Cerebrospinal Fluid Leakage 11 11
Joint Laxity 10 10
Hematoma 10 10
Headache 10 10
Hemorrhage/Bleeding 10 10
Neuropathy 10 10
Loss of Range of Motion 9 9
Disability 9 9
Unspecified Mental, Emotional or Behavioural Problem 8 8
Burning Sensation 8 8
Weakness 8 8
Impaired Healing 8 8
Foreign Body Reaction 8 8
Arthritis 7 7
Purulent Discharge 7 7
Inflammation 7 7

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 ulrich medical USA Inc II Mar-02-2020
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