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TPLC
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show TPLC since
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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
STRYKER
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA) PRODUCTS LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
108
108
2019
122
122
2020
86
86
2021
101
101
2022
61
61
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
204
204
Adverse Event Without Identified Device or Use Problem
155
155
Osseointegration Problem
33
33
Mechanical Jam
13
13
Fracture
12
12
Detachment of Device or Device Component
11
11
Mechanical Problem
9
9
Device-Device Incompatibility
9
9
Device Slipped
7
7
Loosening of Implant Not Related to Bone-Ingrowth
6
6
Device Operates Differently Than Expected
5
5
Migration or Expulsion of Device
4
4
Use of Device Problem
4
4
Difficult to Open or Close
3
3
Detachment Of Device Component
3
3
Migration
3
3
Unintended Movement
2
2
Material Deformation
2
2
Failure to Osseointegrate
2
2
Material Protrusion/Extrusion
2
2
Material Twisted/Bent
2
2
Device Dislodged or Dislocated
2
2
Activation Problem
2
2
Entrapment of Device
2
2
Difficult or Delayed Activation
1
1
Malposition of Device
1
1
Activation Failure
1
1
Premature Separation
1
1
Separation Problem
1
1
Naturally Worn
1
1
Appropriate Term/Code Not Available
1
1
Failure to Align
1
1
Device Abrasion From Instrument Or Another Object
1
1
Human Factors Issue
1
1
Separation Failure
1
1
Patient Device Interaction Problem
1
1
Device Inoperable
1
1
Loss of Osseointegration
1
1
Physical Resistance/Sticking
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Impaired Healing
234
234
No Code Available
48
48
No Consequences Or Impact To Patient
33
33
Unspecified Infection
28
28
No Known Impact Or Consequence To Patient
17
17
Insufficient Information
17
17
No Clinical Signs, Symptoms or Conditions
14
14
Injury
13
13
Device Embedded In Tissue or Plaque
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Non-union Bone Fracture
10
10
Pain
9
9
Inadequate Osseointegration
8
8
Physical Asymmetry
8
8
Abscess
6
6
Cerebrospinal Fluid Leakage
5
5
Failure of Implant
5
5
Post Operative Wound Infection
5
5
Inflammation
5
5
Bone Fracture(s)
4
4
Unspecified Tissue Injury
4
4
Discomfort
4
4
Skull Fracture
3
3
Cellulitis
3
3
Tissue Damage
3
3
Erosion
3
3
Not Applicable
2
2
Nerve Damage
2
2
Pocket Erosion
2
2
Eye Injury
2
2
No Patient Involvement
2
2
Wound Dehiscence
2
2
Cancer
1
1
Neuropathy
1
1
Hearing Impairment
1
1
Deformity/ Disfigurement
1
1
Numbness
1
1
Decreased Sensitivity
1
1
Purulent Discharge
1
1
Laceration(s)
1
1
Scarring
1
1
No Information
1
1
Malunion of Bone
1
1
Swelling/ Edema
1
1
Apnea
1
1
Foreign Body In Patient
1
1
Patient Problem/Medical Problem
1
1
Death
1
1
Hemorrhage/Bleeding
1
1
Necrosis
1
1
Skin Erosion
1
1
Swelling
1
1
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