MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LATERA ABSORBABLE NASAL 2 IMPLANTS GEN 1; EAR, NOSE, AND THROAT SYNTHETIC POLYMER MATERIAL

Catalog Number	LATANI02
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Obstruction/Occlusion (2422); Swelling/ Edema (4577)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch that a patient's nasal implants have not absorbed after 18 months of implantation.The patient reported chronic pain, swelling, and difficulty breathing as a result of obstructed nasal valves.Additional information is currently being requested.
Additional Manufacturer Narrative
Medwatch reports (mw5164285 and mw5164284).
Additional Manufacturer Narrative
Medwatch reports ( mw5164285 and mw5164284).Follow-up report submitted to document the date of initial implant provided by the customer.The device has not been returned for evaluation as the implant is still in the body; hence a root cause could not be determined for the event.
Event or Problem Description
It was reported via medwatch that a patient's nasal implants have not absorbed after 18 months of implantation.The patient reported chronic pain, swelling, and difficulty breathing as a result of obstructed nasal valves.Update 25feb2025: the customer provided additional information that implants were placed on (b)(6) 2023 and the implants are still in the nose.A procedure has been scheduled to remove the implants, the date for the removal of implant is currently unknown.No further information is available at this time on the follow-up surgery.

• Brand Name: LATERA ABSORBABLE NASAL 2 IMPLANTS GEN 1
• Common Device Name: EAR, NOSE, AND THROAT SYNTHETIC POLYMER MATERIAL
• 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: 21274596
• Report Number: 3006345872-2025-00003
• Device Sequence Number: 18160212
• Product Code: NHB
• UDI-Device Identifier: 00857037006013
• UDI-Public: (01)00857037006013(17)241024(10)246690
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K192661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025
• Report Date (Section F): 01/30/2025

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
• Device Expiration Date: 10/24/2024
• Device Catalogue Number: LATANI02
• Device Lot Number: 246690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/12/2025
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/30/2025