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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

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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