MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA 24MM, FINAL KIT; POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE

Catalog Number	LATSYS24
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A full udi is not available due to unknown lot/sn.
Event or Problem Description
It was reported that a patient's nasal implant has not absorbed and is noticeable on the side of their nose.It was also reported that it is painful to wear glasses for long periods of time.Attempts are being made to gather additional details.
Additional Manufacturer Narrative
Follow up report submitted to document additional information from the patient and lot number, gtin.
Event or Problem Description
Additional information from patient indicated bilateral latera implants have not been absorbed after 2 years and the implant is noted by the patient as being over the bridge of the nose causing the patient discomfort while wearing spectacles.The patient visited the treating surgeon at 6 months post surgery at which time the surgeon confirmed the implant has failed and recommended additional intervention as next steps in treatment.However, the patient chose not to proceed with intervention at that time.Currently no intervention has been performed as per the patient and the implant remains in the body.

• Brand Name: LATERA 24MM, FINAL KIT
• Common Device Name: POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22719502
• Report Number: 3006345872-2025-00010
• Device Sequence Number: 18622732
• Product Code: NHB
• UDI-Device Identifier: 00857037006075
• UDI-Public: (01)00857037006075(17)240104(10)A24557
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K161191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: LATSYS24
• Device Lot Number: A24557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown