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TPLC
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2024
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Device
external mandibular fixator and/or distractor
Product Code
MQN
Regulation Number
872.4760
Device Class
2
Premarket Reviews
Manufacturer
Decision
KLS MARTIN L.P.
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA) PRODUCTS LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
122
122
2020
86
86
2021
101
101
2022
61
61
2023
39
39
2024
13
13
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
173
173
Adverse Event Without Identified Device or Use Problem
150
150
Osseointegration Problem
28
28
Mechanical Jam
22
22
Detachment of Device or Device Component
11
11
Device Slipped
8
8
Fracture
8
8
Mechanical Problem
8
8
Device-Device Incompatibility
7
7
Loosening of Implant Not Related to Bone-Ingrowth
6
6
Migration
4
4
Use of Device Problem
3
3
Installation-Related Problem
3
3
Material Deformation
2
2
Material Protrusion/Extrusion
2
2
Material Twisted/Bent
2
2
Difficult to Open or Close
2
2
Loss of Osseointegration
2
2
Activation Problem
2
2
Premature Separation
1
1
Naturally Worn
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Unintended Movement
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Activation Failure
1
1
Patient Device Interaction Problem
1
1
Failure to Align
1
1
Separation Failure
1
1
Difficult or Delayed Activation
1
1
Malposition of Device
1
1
Difficult to Remove
1
1
Entrapment of Device
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Impaired Healing
210
210
No Code Available
40
40
Insufficient Information
27
27
No Clinical Signs, Symptoms or Conditions
27
27
Unspecified Infection
26
26
No Consequences Or Impact To Patient
16
16
Injury
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Non-union Bone Fracture
10
10
Physical Asymmetry
8
8
No Known Impact Or Consequence To Patient
7
7
Failure of Implant
7
7
Pain
6
6
Post Operative Wound Infection
5
5
Inflammation
5
5
Cerebrospinal Fluid Leakage
5
5
Device Embedded In Tissue or Plaque
5
5
Unspecified Tissue Injury
4
4
Abscess
4
4
Bone Fracture(s)
4
4
Discomfort
4
4
Skull Fracture
3
3
Tissue Damage
3
3
Inadequate Osseointegration
3
3
Eye Injury
2
2
Cellulitis
2
2
Nerve Damage
2
2
Neuropathy
1
1
Laceration(s)
1
1
Necrosis
1
1
Neonatal Deformities
1
1
Fistula
1
1
Hearing Impairment
1
1
Hemorrhage/Bleeding
1
1
Apnea
1
1
Purulent Discharge
1
1
Deformity/ Disfigurement
1
1
No Patient Involvement
1
1
Numbness
1
1
Swelling
1
1
Loss of Range of Motion
1
1
Scarring
1
1
Skin Erosion
1
1
Decreased Sensitivity
1
1
Foreign Body In Patient
1
1
Swelling/ Edema
1
1
Malunion of Bone
1
1
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