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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 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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