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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device external mandibular fixator and/or distractor
Regulation Description Bone plate.
Product CodeMQN
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
KLS MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 86 87
2021 101 101
2022 61 61
2023 39 39
2024 60 60
2025 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Break 133 133
Adverse Event Without Identified Device or Use Problem 119 119
Osseointegration Problem 29 29
Fracture 23 23
Mechanical Jam 21 21
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
Activation Problem 4 4
Material Separation 4 4
Loss of Osseointegration 4 4
Entrapment of Device 3 3
Use of Device Problem 3 3
Material Twisted/Bent 3 3
Installation-Related Problem 3 3
Difficult to Advance 2 2
Material Deformation 2 2
Difficult to Open or Close 2 2
Malposition of Device 1 2
Physical Resistance/Sticking 1 1
Separation Failure 1 1
Insufficient Information 1 1
Difficult to Remove 1 1
Failure to Align 1 2
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 49 49
No Clinical Signs, Symptoms or Conditions 38 38
Unspecified Infection 17 17
No Code Available 17 17
Physical Asymmetry 14 14
Inadequate Osseointegration 13 13
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
Blister 4 4
Unspecified Tissue Injury 4 4
Abscess 4 4
Skull Fracture 3 3
Bone Fracture(s) 3 3
Foreign Body In Patient 3 3
Fistula 2 2
Tissue Damage 2 3
Cerebrospinal Fluid Leakage 2 2
Discomfort 2 2
Nerve Damage 2 2
No Known Impact Or Consequence To Patient 2 2
Swelling 1 1
Numbness 1 1
No Patient Involvement 1 1
Loss of Range of Motion 1 1
Laceration(s) 1 1
Skin Erosion 1 1
Malunion of Bone 1 1
Movement Disorder 1 1
Bruxism 1 1
Swelling/ Edema 1 1
Purulent Discharge 1 1
Neonatal Deformities 1 1
Necrosis 1 1
Hemorrhage/Bleeding 1 1
Decreased Sensitivity 1 1
Deformity/ Disfigurement 1 1
Cancer 1 1
Apnea 1 1

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