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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 2
OXFORD PERFORMANCE MATERIALS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 17
Inadequacy of Device Shape and/or Size 16
Insufficient Information 14
Fracture 10
Fitting Problem 8
Migration or Expulsion of Device 5
Patient-Device Incompatibility 5
Material Fragmentation 4
Device Markings / Labelling Problem 3
Appropriate Term/Code Not Available 3
Break 2
Crack 2
Screw 1
Device Dislodged or Dislocated 1
Device Handling Problem 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Unsealed Device Packaging 1
Difficult To Position 1
Device Packaging Compromised 1
Manufacturing, Packaging or Shipping Problem 1
Structural Problem 1
Noise, Audible 1
Total Device Problems 99

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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