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TPLC
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Device
appliance, fixation, spinal interlaminal
Regulation Description
Spinal interlaminal fixation orthosis.
Product Code
KWP
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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