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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
SYNTHES USA PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 75 75
2018 108 108
2019 122 122
2020 86 86
2021 101 101
2022 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Break 221 221
Adverse Event Without Identified Device or Use Problem 162 162
Osseointegration Problem 36 36
Fracture 27 27
Mechanical Jam 15 15
Device Operates Differently Than Expected 14 14
Detachment of Device or Device Component 12 12
Device-Device Incompatibility 9 9
Mechanical Problem 9 9
Detachment Of Device Component 8 8
Device Slipped 8 8
Migration or Expulsion of Device 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Use of Device Problem 5 5
Unintended Movement 5 5
Difficult to Open or Close 3 3
Device Dislodged or Dislocated 3 3
Migration 3 3
Activation Problem 2 2
Human Factors Issue 2 2
Material Deformation 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Positioning Problem 2 2
Failure to Osseointegrate 2 2
Improper or Incorrect Procedure or Method 2 2
Entrapment of Device 2 2
Device Inoperable 2 2
Loose or Intermittent Connection 2 2
Device Abrasion From Instrument Or Another Object 1 1
Disassembly 1 1
Failure To Adhere Or Bond 1 1
Bent 1 1
Loss of Osseointegration 1 1
Failure to Align 1 1
Difficult or Delayed Activation 1 1
Malposition of Device 1 1
Naturally Worn 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Separation Problem 1 1
Premature Separation 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 235 235
No Code Available 67 67
No Consequences Or Impact To Patient 39 39
No Known Impact Or Consequence To Patient 38 38
Unspecified Infection 31 31
Insufficient Information 15 15
Inadequate Osseointegration 14 14
Device Embedded In Tissue or Plaque 13 13
No Clinical Signs, Symptoms or Conditions 13 13
Injury 13 13
Non-union Bone Fracture 11 11
Pain 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Failure of Implant 10 10
Physical Asymmetry 8 8
Post Operative Wound Infection 6 6
Abscess 6 6
Cerebrospinal Fluid Leakage 5 5
Inflammation 4 4
Bone Fracture(s) 4 4
Discomfort 4 4
Unspecified Tissue Injury 4 4
Tissue Damage 3 3
Skull Fracture 3 3
Erosion 3 3
Cellulitis 3 3
Wound Dehiscence 2 2
Eye Injury 2 2
Fatigue 2 2
Swelling 2 2
Nerve Damage 2 2
Pocket Erosion 2 2
Reaction 2 2
No Patient Involvement 2 2
Not Applicable 2 2
Foreign Body In Patient 2 2
Patient Problem/Medical Problem 1 1
Cancer 1 1
Malunion of Bone 1 1
Swelling/ Edema 1 1
No Information 1 1
Decreased Sensitivity 1 1
Numbness 1 1
Deformity/ Disfigurement 1 1
Loss of Range of Motion 1 1
Scarring 1 1
Skin Erosion 1 1
Neuropathy 1 1
Laceration(s) 1 1
Fall 1 1
Hearing Impairment 1 1
Hemorrhage/Bleeding 1 1
Abrasion 1 1
Apnea 1 1
Death 1 1
Purulent Discharge 1 1

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