Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 8 12

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 13 17
Expulsion 6 6
Break 3 3
Fracture 3 3
Patient-Device Incompatibility 3 3
Migration 2 2
Device Dislodged or Dislocated 2 2
Packaging Problem 2 2
Detachment of Device or Device Component 2 2
Scratched Material 1 1
Sharp Edges 1 1
Device Handling Problem 1 1
Material Protrusion/Extrusion 1 1
Material Separation 1 1
Use of Device Problem 1 1
Appropriate Term/Code Not Available 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 13 17
Pain 9 9
Inflammation 8 8
Hematoma 6 6
Visual Impairment 5 5
Visual Disturbances 5 5
Discomfort 5 9
Obstruction/Occlusion 4 4
Pocket Erosion 4 4
Scar Tissue 4 4
Unspecified Infection 4 4
Edema 3 3
Deformity/ Disfigurement 3 3
No Known Impact Or Consequence To Patient 3 3
Subcutaneous Nodule 3 3
Insufficient Information 2 2
Swelling 2 2
No Code Available 2 2
Impaired Healing 2 2
Nasal Obstruction 2 2
No Consequences Or Impact To Patient 2 2
Necrosis 2 2
Fistula 2 2
Foreign Body Reaction 2 2
Failure of Implant 2 6
Bacterial Infection 2 2
Cellulitis 2 2
Cerebrospinal Fluid Leakage 2 2
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
Erythema 1 1
Eye Injury 1 1
Sepsis 1 1
Seroma 1 1
Skin Discoloration 1 1
Foreign Body In Patient 1 1
Fibrosis 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
-
-