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TPLC
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Device
external mandibular fixator and/or distractor
Regulation Description
Bone plate.
Product Code
MQN
Regulation Number
872.4760
Device Class
2
Premarket Reviews
Manufacturer
Decision
KLS MARTIN L.P.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
86
86
2021
101
101
2022
61
61
2023
39
39
2024
60
60
2025
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
130
130
Adverse Event Without Identified Device or Use Problem
119
119
Osseointegration Problem
28
28
Mechanical Jam
21
21
Fracture
13
13
Detachment of Device or Device Component
11
11
Device-Device Incompatibility
10
10
Migration
10
10
Device Slipped
8
8
Loosening of Implant Not Related to Bone-Ingrowth
6
6
Mechanical Problem
5
5
Loss of Osseointegration
4
4
Entrapment of Device
3
3
Use of Device Problem
3
3
Material Twisted/Bent
3
3
Material Separation
3
3
Installation-Related Problem
3
3
Activation Problem
2
2
Material Deformation
2
2
Difficult to Open or Close
2
2
Malposition of Device
1
1
Physical Resistance/Sticking
1
1
Separation Failure
1
1
Insufficient Information
1
1
Difficult to Remove
1
1
Failure to Align
1
1
Difficult or Delayed Activation
1
1
Material Protrusion/Extrusion
1
1
Activation Failure
1
1
Appropriate Term/Code Not Available
1
1
Premature Separation
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Impaired Healing
160
160
Insufficient Information
36
36
No Clinical Signs, Symptoms or Conditions
35
35
Unspecified Infection
17
17
No Code Available
17
17
Physical Asymmetry
14
14
Inadequate Osseointegration
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Non-union Bone Fracture
11
11
Injury
10
10
Pain
9
9
No Consequences Or Impact To Patient
8
8
Failure of Implant
6
6
Inflammation
5
5
Post Operative Wound Infection
5
5
Unspecified Tissue Injury
4
4
Abscess
4
4
Blister
4
4
Foreign Body In Patient
3
3
Bone Fracture(s)
3
3
Skull Fracture
3
3
No Known Impact Or Consequence To Patient
2
2
Nerve Damage
2
2
Discomfort
2
2
Cerebrospinal Fluid Leakage
2
2
Tissue Damage
2
2
Fistula
2
2
Skin Erosion
1
1
Movement Disorder
1
1
Loss of Range of Motion
1
1
Swelling
1
1
Numbness
1
1
No Patient Involvement
1
1
Purulent Discharge
1
1
Laceration(s)
1
1
Malunion of Bone
1
1
Neonatal Deformities
1
1
Necrosis
1
1
Swelling/ Edema
1
1
Decreased Sensitivity
1
1
Hemorrhage/Bleeding
1
1
Apnea
1
1
Deformity/ Disfigurement
1
1
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