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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
Regulation Description Polytetrafluoroethylene with carbon fibers composite implant material.
Product CodeKKY
Regulation Number 878.3500
Device Class 2


Premarket Reviews
ManufacturerDecision
CEREMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXFORD PERFORMANCE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 25 25
2017 19 19
2018 17 17
2019 20 20
2020 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 25
Inadequacy of Device Shape and/or Size 18 18
Insufficient Information 12 12
Fracture 10 10
Fitting Problem 8 8
Patient-Device Incompatibility 4 4
Material Fragmentation 4 4
Migration or Expulsion of Device 4 4
Appropriate Term/Code Not Available 4 4
Crack 3 3
Break 2 2
Device Markings/Labelling Problem 2 2
Device Packaging Compromised 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Inaccurate Information 1 1
Unsealed Device Packaging 1 1
Device Appears to Trigger Rejection 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 20 20
No Code Available 20 20
Unspecified Infection 19 19
No Information 7 7
No Consequences Or Impact To Patient 6 6
No Patient Involvement 5 5
Patient Problem/Medical Problem 3 3
Post Operative Wound Infection 3 3
Impaired Healing 2 2
Purulent Discharge 2 2
Edema 2 2
Injury 2 2
Inflammation 2 2
Irritation 1 1
Staphylococcus Aureus 1 1
Ulceration 1 1
Erosion 1 1
Cerebrospinal Fluid Leakage 1 1
Erythema 1 1
Fall 1 1
Failure of Implant 1 1
Discharge 1 1
Skin Tears 1 1
Depression 1 1
Fistula 1 1
Laceration(s) 1 1
Pocket Erosion 1 1
Infection, Pyrogenic 1 1
Bacterial Infection 1 1
Hydrocephalus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet Microfixation, LLC II Sep-08-2016
2 Matrix Surgical Holdings, LLC II Apr-27-2019
3 Matrix Surgical Holdings, LLC II Feb-28-2017
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