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

Catalog Number	LATSYS24
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Tissue Breakdown (2681); Unspecified Respiratory Problem (4464)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the latera implant was placed bilaterally in (b)(6) 2024 and the right latera implant migrated upwards approximately 1 mm away from the tear duct and occurred several hours after they were implanted.The patient has reported difficulty in breathing through the right nostril.There has been no reported medical intervention.Additional information is currently being requested.
Additional Manufacturer Narrative
The device remains implanted in the nasal anatomy and not returned for evaluation; a root cause could not be determined for the event.
Event or Problem Description
Cbased on review of communication with the patient, the patient had 24 mm implants placed in the anatomy.Upon further investigation it was determined the patient was wearing spectacles, which may have caused or contributed to the reported event.

• 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: 22109028
• Report Number: 3006345872-2025-00007
• Device Sequence Number: 20633548
• Product Code: NHB
• UDI-Device Identifier: 00857037006075
• UDI-Public: (01)00857037006075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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
• Device Catalogue Number: LATSYS24
• Device Lot Number: UNKNOWN
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 61 YR
• Patient Sex: Unknown