Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 122 122
2020 86 86
2021 101 101
2022 61 61
2023 39 39
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Break 173 173
Adverse Event Without Identified Device or Use Problem 150 150
Osseointegration Problem 28 28
Mechanical Jam 22 22
Detachment of Device or Device Component 11 11
Device Slipped 8 8
Fracture 8 8
Mechanical Problem 8 8
Device-Device Incompatibility 7 7
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Migration 4 4
Use of Device Problem 3 3
Installation-Related Problem 3 3
Material Deformation 2 2
Material Protrusion/Extrusion 2 2
Material Twisted/Bent 2 2
Difficult to Open or Close 2 2
Loss of Osseointegration 2 2
Activation Problem 2 2
Premature Separation 1 1
Naturally Worn 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Activation Failure 1 1
Patient Device Interaction Problem 1 1
Failure to Align 1 1
Separation Failure 1 1
Difficult or Delayed Activation 1 1
Malposition of Device 1 1
Difficult to Remove 1 1
Entrapment of Device 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 210 210
No Code Available 40 40
Insufficient Information 27 27
No Clinical Signs, Symptoms or Conditions 27 27
Unspecified Infection 26 26
No Consequences Or Impact To Patient 16 16
Injury 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Non-union Bone Fracture 10 10
Physical Asymmetry 8 8
No Known Impact Or Consequence To Patient 7 7
Failure of Implant 7 7
Pain 6 6
Post Operative Wound Infection 5 5
Inflammation 5 5
Cerebrospinal Fluid Leakage 5 5
Device Embedded In Tissue or Plaque 5 5
Unspecified Tissue Injury 4 4
Abscess 4 4
Bone Fracture(s) 4 4
Discomfort 4 4
Skull Fracture 3 3
Tissue Damage 3 3
Inadequate Osseointegration 3 3
Eye Injury 2 2
Cellulitis 2 2
Nerve Damage 2 2
Neuropathy 1 1
Laceration(s) 1 1
Necrosis 1 1
Neonatal Deformities 1 1
Fistula 1 1
Hearing Impairment 1 1
Hemorrhage/Bleeding 1 1
Apnea 1 1
Purulent Discharge 1 1
Deformity/ Disfigurement 1 1
No Patient Involvement 1 1
Numbness 1 1
Swelling 1 1
Loss of Range of Motion 1 1
Scarring 1 1
Skin Erosion 1 1
Decreased Sensitivity 1 1
Foreign Body In Patient 1 1
Swelling/ Edema 1 1
Malunion of Bone 1 1

-
-