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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 14 18

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 16 20
Expulsion 6 6
Fracture 4 4
Break 3 3
Patient-Device Incompatibility 3 3
Detachment of Device or Device Component 2 2
Migration 2 2
Device Dislodged or Dislocated 2 2
Improper or Incorrect Procedure or Method 2 2
Packaging Problem 2 2
Migration or Expulsion of Device 1 1
Expiration Date Error 1 1
Scratched Material 1 1
Use of Device Problem 1 1
Sharp Edges 1 1
Material Protrusion/Extrusion 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Appropriate Term/Code Not Available 1 1
Device Appears to Trigger Rejection 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 17 17
No Clinical Signs, Symptoms or Conditions 15 19
Pain 9 9
Inflammation 8 8
Subcutaneous Nodule 6 6
Hematoma 6 6
Discomfort 6 10
Visual Impairment 5 5
Visual Disturbances 5 5
Unspecified Infection 4 4
Pocket Erosion 4 4
Obstruction/Occlusion 4 4
Scar Tissue 4 4
Deformity/ Disfigurement 3 3
Failure of Implant 3 7
Edema 3 3
No Known Impact Or Consequence To Patient 3 3
Fistula 2 2
Bacterial Infection 2 2
No Consequences Or Impact To Patient 2 2
Cerebrospinal Fluid Leakage 2 2
Nasal Obstruction 2 2
Insufficient Information 2 2
Swelling 2 2
Cellulitis 2 2
Foreign Body Reaction 2 2
Necrosis 2 2
No Code Available 2 2
Skin Infection 2 2
Impaired Healing 2 2
Erythema 1 1
Seroma 1 1
Foreign Body In Patient 1 1
Skin Discoloration 1 1
Cyst(s) 1 1
Abscess 1 1
Eye Injury 1 1
Calcium Deposits/Calcification 1 1
Adhesion(s) 1 1
Erosion 1 1
Sepsis 1 1
Fibrosis 1 1
Hemorrhage/Bleeding 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bruise/Contusion 1 1

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