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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 332 332
2024 375 375

Device Problems MDRs with this Device Problem Events in those MDRs
Break 881 881
Adverse Event Without Identified Device or Use Problem 343 343
Device Slipped 267 267
Migration 214 214
Loosening of Implant Not Related to Bone-Ingrowth 188 188
Material Deformation 151 151
Device Dislodged or Dislocated 138 138
Fracture 127 127
Failure to Align 81 81
Migration or Expulsion of Device 77 77
Detachment of Device or Device Component 55 55
Mechanical Problem 47 47
Device Appears to Trigger Rejection 46 46
Mechanics Altered 40 40
Device-Device Incompatibility 39 39
Material Twisted/Bent 39 39
Loose or Intermittent Connection 39 39
No Apparent Adverse Event 31 31
Mechanical Jam 27 27
Malposition of Device 24 24
Material Integrity Problem 24 24
Use of Device Problem 19 19
Device Damaged by Another Device 16 16
Appropriate Term/Code Not Available 13 13
Patient-Device Incompatibility 11 11
Insufficient Information 11 11
Material Separation 10 10
Failure to Osseointegrate 10 10
Crack 9 9
Packaging Problem 9 9
Entrapment of Device 9 9
Expulsion 8 8
Compatibility Problem 8 8
Scratched Material 7 7
Patient Device Interaction Problem 7 7
Naturally Worn 7 7
Product Quality Problem 6 6
Material Fragmentation 6 6
Difficult to Advance 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Difficult to Insert 4 4
Degraded 4 4
Osseointegration Problem 4 4
Unintended Movement 4 4
Biocompatibility 4 4
Corroded 3 3
Material Erosion 3 3
Material Disintegration 3 3
Activation, Positioning or Separation Problem 3 3
Failure to Advance 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 967 967
No Known Impact Or Consequence To Patient 583 583
Pain 444 444
Failure of Implant 188 188
No Code Available 99 99
Unspecified Infection 75 75
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 74 74
Insufficient Information 72 72
Device Embedded In Tissue or Plaque 67 67
Seroma 67 67
Bone Fracture(s) 56 56
Implant Pain 53 53
Injury 41 41
No Patient Involvement 38 38
Post Operative Wound Infection 35 35
Non-union Bone Fracture 33 33
Foreign Body In Patient 31 31
Stenosis 28 28
No Consequences Or Impact To Patient 25 25
Ambulation Difficulties 24 24
Discomfort 24 24
Spinal Column Injury 21 21
Nerve Damage 21 21
Paralysis 20 20
Numbness 19 19
Patient Problem/Medical Problem 19 19
Spinal Cord Injury 17 17
Neurological Deficit/Dysfunction 17 17
Fall 16 16
Inadequate Osseointegration 16 16
Neck Pain 16 16
No Information 14 14
Unspecified Nervous System Problem 14 14
Neuropathy 14 14
Osteolysis 12 12
Unspecified Tissue Injury 12 12
Cerebrospinal Fluid Leakage 11 11
Hematoma 11 11
Joint Laxity 10 10
Headache 10 10
Hemorrhage/Bleeding 10 10
Disability 9 9
Weakness 9 9
Impaired Healing 9 9
Burning Sensation 8 8
Reaction 7 7
Purulent Discharge 7 7
Swelling/ Edema 6 6
Swelling 6 6
Arthritis 6 6

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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