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TPLC
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show TPLC since
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Device
orthosis, spondylolisthesis spinal fixation
Product Code
MNH
Regulation Number
888.3070
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
403
403
2020
442
442
2021
543
543
2022
266
266
2023
122
122
2024
285
285
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
775
775
Break
218
218
Migration
152
152
No Apparent Adverse Event
128
128
Loose or Intermittent Connection
106
106
Device Slipped
93
93
Insufficient Information
64
64
Unintended Movement
64
64
Appropriate Term/Code Not Available
53
53
Device-Device Incompatibility
47
47
Patient Device Interaction Problem
46
46
Material Integrity Problem
44
44
Loosening of Implant Not Related to Bone-Ingrowth
39
39
Fracture
38
38
Detachment of Device or Device Component
37
37
Migration or Expulsion of Device
33
33
Material Twisted/Bent
33
33
Material Deformation
28
28
Device Dislodged or Dislocated
27
27
Mechanical Problem
20
20
Use of Device Problem
19
19
Human-Device Interface Problem
18
18
Material Separation
18
18
Compatibility Problem
12
12
Entrapment of Device
11
11
Fluid/Blood Leak
9
9
Physical Resistance/Sticking
9
9
Product Quality Problem
8
8
Material Fragmentation
8
8
Improper or Incorrect Procedure or Method
5
5
Device Handling Problem
5
5
Improper Chemical Reaction
4
4
Mechanical Jam
4
4
Corroded
4
4
Difficult to Advance
4
4
Difficult to Remove
4
4
Mechanics Altered
4
4
Noise, Audible
3
3
Inaccurate Information
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Activation, Positioning or Separation Problem
3
3
Positioning Failure
2
2
Material Protrusion/Extrusion
2
2
Positioning Problem
2
2
Patient-Device Incompatibility
2
2
Crack
2
2
Output Problem
2
2
Malposition of Device
2
2
Loss of or Failure to Bond
2
2
Inflation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
402
402
Insufficient Information
327
327
No Clinical Signs, Symptoms or Conditions
267
267
Pain
259
259
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
173
173
Failure of Implant
159
159
Non-union Bone Fracture
127
127
Unspecified Infection
104
104
Bone Fracture(s)
88
88
Nerve Damage
86
86
Injury
74
74
Neurological Deficit/Dysfunction
70
70
Post Operative Wound Infection
68
68
Osteolysis
64
64
No Consequences Or Impact To Patient
61
61
Unspecified Tissue Injury
53
53
Hematoma
49
49
Spinal Column Injury
44
44
Cerebrospinal Fluid Leakage
36
36
Spinal Cord Injury
31
31
Paralysis
31
31
Hypoesthesia
30
30
Unspecified Nervous System Problem
30
30
Dysphagia/ Odynophagia
29
29
Impaired Healing
26
26
No Known Impact Or Consequence To Patient
23
23
Physical Asymmetry
22
22
Joint Laxity
18
18
No Patient Involvement
17
17
Death
16
16
Foreign Body In Patient
14
14
Discomfort
12
12
Perforation of Vessels
11
11
Hemorrhage/Bleeding
10
10
Wound Dehiscence
9
9
Stenosis
9
9
Neck Pain
9
9
Deformity/ Disfigurement
9
9
Seroma
9
9
Loss of Range of Motion
8
8
Numbness
8
8
Fall
8
8
Thromboembolism
8
8
Decreased Sensitivity
8
8
Necrosis
7
7
Fatigue
7
7
Tissue Damage
6
6
Weakness
6
6
Implant Pain
6
6
Inflammation
6
6
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