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TPLC
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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
2018
129
129
2019
403
403
2020
442
442
2021
543
543
2022
265
265
2023
89
89
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
745
745
Break
240
240
No Apparent Adverse Event
124
124
Loose or Intermittent Connection
112
112
Migration
110
110
Device Slipped
84
84
Unintended Movement
64
64
Appropriate Term/Code Not Available
52
52
Device-Device Incompatibility
52
52
Loosening of Implant Not Related to Bone-Ingrowth
40
40
Patient Device Interaction Problem
39
39
Material Integrity Problem
39
39
Migration or Expulsion of Device
37
37
Fracture
34
34
Material Twisted/Bent
32
32
Material Deformation
30
30
Detachment of Device or Device Component
23
23
Insufficient Information
21
21
Device Dislodged or Dislocated
19
19
Mechanical Problem
16
16
Material Separation
15
15
Compatibility Problem
14
14
Entrapment of Device
11
11
Physical Resistance/Sticking
7
7
Material Split, Cut or Torn
5
5
Mechanical Jam
5
5
Fluid/Blood Leak
5
5
Fitting Problem
5
5
Difficult to Advance
4
4
Corroded
4
4
Difficult to Remove
4
4
Mechanics Altered
4
4
Material Protrusion/Extrusion
4
4
Positioning Problem
4
4
Activation, Positioning or Separation Problem
3
3
Inaccurate Information
3
3
Noise, Audible
3
3
Component Missing
3
3
Improper or Incorrect Procedure or Method
2
2
Improper Chemical Reaction
2
2
Malposition of Device
2
2
Patient-Device Incompatibility
2
2
Crack
2
2
Positioning Failure
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Output Problem
2
2
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Osseointegration Problem
1
1
Failure to Eject
1
1
Disconnection
1
1
Display or Visual Feedback Problem
1
1
Collapse
1
1
Detachment Of Device Component
1
1
Partial Blockage
1
1
Device Appears to Trigger Rejection
1
1
Material Fragmentation
1
1
Inflation Problem
1
1
Connection Problem
1
1
Device Damaged by Another Device
1
1
Device Inoperable
1
1
Structural Problem
1
1
Defective Device
1
1
Defective Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
440
440
Pain
258
258
No Clinical Signs, Symptoms or Conditions
246
246
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
170
170
Failure of Implant
148
148
Insufficient Information
131
131
Non-union Bone Fracture
120
120
Unspecified Infection
110
110
Bone Fracture(s)
80
80
Injury
79
79
No Consequences Or Impact To Patient
75
75
Neurological Deficit/Dysfunction
70
70
No Known Impact Or Consequence To Patient
69
69
Nerve Damage
68
68
Post Operative Wound Infection
65
65
Osteolysis
44
44
Unspecified Tissue Injury
43
43
Hematoma
42
42
Paralysis
31
31
Cerebrospinal Fluid Leakage
30
30
Hypoesthesia
30
30
Dysphagia/ Odynophagia
24
24
Unspecified Nervous System Problem
24
24
Physical Asymmetry
22
22
Impaired Healing
21
21
Spinal Cord Injury
21
21
No Patient Involvement
17
17
Death
16
16
Foreign Body In Patient
13
13
Discomfort
12
12
Perforation of Vessels
10
10
Hemorrhage/Bleeding
10
10
Wound Dehiscence
9
9
Seroma
9
9
Spinal Column Injury
8
8
Deformity/ Disfigurement
8
8
Stenosis
8
8
Neck Pain
7
7
Necrosis
7
7
Fall
7
7
Numbness
7
7
No Information
7
7
Loss of Range of Motion
6
6
Weakness
6
6
Thrombosis
6
6
Tissue Damage
6
6
Fatigue
5
5
Hypersensitivity/Allergic reaction
5
5
Inflammation
5
5
Muscular Rigidity
5
5
Joint Laxity
5
5
Limited Mobility Of The Implanted Joint
4
4
Incontinence
4
4
Ossification
4
4
Abscess
4
4
Skin Irritation
3
3
Decreased Sensitivity
3
3
Device Embedded In Tissue or Plaque
3
3
Blood Loss
3
3
Metal Related Pathology
3
3
Swelling/ Edema
3
3
Unspecified Musculoskeletal problem
2
2
Intervertebral Disc Compression or Protrusion
2
2
Implant Pain
2
2
Inadequate Osseointegration
2
2
Thromboembolism
2
2
Ambulation Difficulties
2
2
Pseudoaneurysm
2
2
Urinary Tract Infection
2
2
Burning Sensation
2
2
Tingling
2
2
Swelling
2
2
Reaction
2
2
Bacterial Infection
2
2
Pulmonary Embolism
2
2
Headache
2
2
Nausea
2
2
Stroke/CVA
2
2
Itching Sensation
2
2
Paresis
2
2
Pneumonia
2
2
Irritation
1
1
Purulent Discharge
1
1
Fever
1
1
Erosion
1
1
Bruise/Contusion
1
1
Calcium Deposits/Calcification
1
1
Cellulitis
1
1
Adhesion(s)
1
1
Anemia
1
1
Arthritis
1
1
Complaint, Ill-Defined
1
1
Pressure Sores
1
1
Rupture
1
1
Hernia
1
1
Depression
1
1
Skin Erosion
1
1
Cramp(s)
1
1
Urinary Retention
1
1
Fibrosis
1
1
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