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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, chin, internal
Product CodeFWP
Regulation Number 878.3550
Device Class 2


Premarket Reviews
ManufacturerDecision
IMPLANTECH ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 2
KEOSAN TRADING CO.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 6 6
2021 13 13
2022 12 12
2023 6 6
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 24 24
Insufficient Information 5 5
Device Dislodged or Dislocated 4 4
Inadequacy of Device Shape and/or Size 4 4
Appropriate Term/Code Not Available 3 3
Device Appears to Trigger Rejection 2 2
Expulsion 2 2
Output Problem 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 1 1
No Apparent Adverse Event 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Difficult to Remove 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Material Erosion 1 1
Fracture 1 1
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 16 16
Pain 7 7
Bacterial Infection 6 6
Impaired Healing 4 4
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Swelling/ Edema 3 3
Fluid Discharge 3 3
No Code Available 3 3
Cerebral Edema 2 2
Pocket Erosion 2 2
Failure of Implant 2 2
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Meningitis 2 2
Post Operative Wound Infection 2 2
Skin Erosion 2 2
Inflammation 2 2
Wound Dehiscence 1 1
Airway Obstruction 1 1
Purulent Discharge 1 1
Ecchymosis 1 1
Edema 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Swelling 1 1
Discomfort 1 1
Deformity/ Disfigurement 1 1
Inadequate Osseointegration 1 1
Loss of Range of Motion 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Skin Infection 1 1
Physical Asymmetry 1 1

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