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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device polymer, ear, nose and throat, synthetic, absorbable
Definition Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.
Product CodeNHB
Regulation Number 874.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
3-D MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENTELLUS MEDICAL, INC. (AKA STRYKER ENT)
  SUBSTANTIALLY EQUIVALENT 1
HEMOSTASIS LLC
  SUBSTANTIALLY EQUIVALENT 1
SPIRAIR, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 27 27
2020 6 6
2021 16 16
2022 9 9
2023 8 8
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36 36
Patient Device Interaction Problem 11 11
Expulsion 6 6
Patient-Device Incompatibility 3 3
Break 3 3
Fracture 3 3
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 2 2
Migration 2 2
Packaging Problem 2 2
Scratched Material 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Sharp Edges 1 1
Material Protrusion/Extrusion 1 1
Material Separation 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Tear, Rip or Hole in Device Packaging 1 1
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 17 17
No Clinical Signs, Symptoms or Conditions 11 11
Pain 9 9
Inflammation 8 8
Hematoma 6 6
Visual Impairment 5 5
Visual Disturbances 5 5
Unspecified Infection 4 4
Pocket Erosion 4 4
Discomfort 4 4
Obstruction/Occlusion 4 4
Deformity/ Disfigurement 3 3
No Known Impact Or Consequence To Patient 3 3
Scar Tissue 3 3
Edema 3 3
Subcutaneous Nodule 3 3
Insufficient Information 2 2
Fistula 2 2
Foreign Body Reaction 2 2
Necrosis 2 2
Bacterial Infection 2 2
Cellulitis 2 2
Cerebrospinal Fluid Leakage 2 2
Swelling 2 2
No Consequences Or Impact To Patient 2 2
No Code Available 2 2
Impaired Healing 2 2
Nasal Obstruction 2 2
Foreign Body In Patient 1 1
Fibrosis 1 1
Sepsis 1 1
Seroma 1 1
Skin Discoloration 1 1
Cyst(s) 1 1
Abscess 1 1
Adhesion(s) 1 1
Erosion 1 1
Bruise/Contusion 1 1
Calcium Deposits/Calcification 1 1
Hemorrhage/Bleeding 1 1
Failure of Implant 1 1
Erythema 1 1
Eye Injury 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3-D Matrix, Inc. II Mar-10-2022
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