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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
Product CodeMQN
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
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
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 205 205
Adverse Event Without Identified Device or Use Problem 156 156
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
Migration 3 3
Detachment Of Device Component 3 3
Material Deformation 2 2
Unintended Movement 2 2
Material Protrusion/Extrusion 2 2
Entrapment of Device 2 2
Failure to Osseointegrate 2 2
Material Twisted/Bent 2 2
Device Dislodged or Dislocated 2 2
Activation Problem 2 2
Device Abrasion From Instrument Or Another Object 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Device Fell 1 1
Device Inoperable 1 1
Difficult or Delayed Activation 1 1
Malposition of Device 1 1
Premature Separation 1 1
Failure to Align 1 1
Naturally Worn 1 1
Separation Problem 1 1
Patient Device Interaction Problem 1 1
Separation Failure 1 1
Human Factors Issue 1 1
Physical Resistance/Sticking 1 1
Loss of Osseointegration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 235 235
No Code Available 48 48
No Consequences Or Impact To Patient 33 33
Unspecified Infection 28 28
Insufficient Information 17 17
No Known Impact Or Consequence To Patient 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
Physical Asymmetry 8 8
Inadequate Osseointegration 8 8
Abscess 6 6
Cerebrospinal Fluid Leakage 5 5
Post Operative Wound Infection 5 5
Failure of Implant 5 5
Inflammation 5 5
Unspecified Tissue Injury 4 4
Bone Fracture(s) 4 4
Discomfort 4 4
Erosion 3 3
Tissue Damage 3 3
Cellulitis 3 3
Skull Fracture 3 3
Pocket Erosion 2 2
Eye Injury 2 2
No Patient Involvement 2 2
Not Applicable 2 2
Nerve Damage 2 2
Wound Dehiscence 2 2
Neuropathy 1 1
Numbness 1 1
Decreased Sensitivity 1 1
Cancer 1 1
Scarring 1 1
Purulent Discharge 1 1
Skin Erosion 1 1
Patient Problem/Medical Problem 1 1
No Information 1 1
Swelling/ Edema 1 1
Apnea 1 1
Hemorrhage/Bleeding 1 1
Necrosis 1 1
Malunion of Bone 1 1
Death 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Laceration(s) 1 1
Hearing Impairment 1 1
Deformity/ Disfigurement 1 1

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