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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction
Product CodeKKY
Regulation Number 878.3500
Device Class 2


Premarket Reviews
ManufacturerDecision
LONGEVITI NEURO SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 20 20
2020 13 13
2021 12 12
2022 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21 21
Inadequacy of Device Shape and/or Size 8 8
Insufficient Information 6 6
Appropriate Term/Code Not Available 3 3
Break 2 2
Fitting Problem 2 2
Labelling, Instructions for Use or Training Problem 2 2
Loose or Intermittent Connection 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Crack 1 1
Fracture 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
Unspecified Infection 8 8
Post Operative Wound Infection 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Patient Problem/Medical Problem 3 3
No Information 3 3
Insufficient Information 2 2
No Patient Involvement 2 2
Edema 2 2
Pain 2 2
Inflammation 2 2
Erosion 2 2
Bruise/Contusion 1 1
Cerebrospinal Fluid Leakage 1 1
Wound Dehiscence 1 1
Bacterial Infection 1 1
Laceration(s) 1 1
Necrosis 1 1
Pocket Erosion 1 1
No Consequences Or Impact To Patient 1 1
Infection, Pyrogenic 1 1
Injury 1 1
Depression 1 1
Impaired Healing 1 1
Hemorrhage/Bleeding 1 1
Fluid Discharge 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Matrix Surgical Holdings, LLC II Apr-27-2019
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